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Clinical Trial Manager Associate

Instil Bio is a global clinical-stage biotechnology company focused on the development of novel immuno-oncology treatments called tumor infiltrating lymphocytes (TILs). TILs are naturally occurring immune cells that have the ability to identify and destroy cancer cells. Instil Bio is engineering TILs to harness and amplify their cancer fighting ability to treat of a broad range of solid tumor cancers.  Instil Bio is located in southern California with additional manufacturing and research facilities in Manchester U.K.

Instil Bio is seeking a Clinical Trial Manager Associate (CTMA) responsible for assisting/supporting the CTM in managing all aspects of clinical trial conduct beginning with study start-up through trial close-out. Responsibilities include but, are not limited to:

Leadership

  • Support all stages of trial conduct beginning with study design, study start-up, patient enrollment, study conduct, and trial close-out.
  • Support the clinical operations team ensuring study goals are delivered on time, on budget, and with a high degree of quality.
  • Under supervision organize and schedule study team meetings including agendas, meeting minutes, assignment of tasks, and resolution of outstanding items.
  • Interact with cross functional departments (i.e., Clinical Development, Biometrics, Regulatory Affairs, Safety, Translational Sciences, and Clinical Supply Chain etc.)
  • Help to ensure trial activities are completed in compliance with Code of Federal Regulations (CFR), ICH/GCP guidelines, local regulatory requirements, and company SOPs
  • Participate in the development, review and implementation of department SOPs/processes

Study Design & Study Start-Up

  • Participate in the review of trial related documents including protocols, informed consent forms, case report forms, study conduct plans, and clinical study reports.
  • Support country and site feasibility to identify and recruit clinical investigators.
  • Support the collection of essential documents necessary for site activation. 
  • Help to track site study start-up status (i.e. SRC and IRB meetings dates, regulatory approval status, and budget/contract execution)
  • Assist with the submission, tracking and maintenance of clinical study documents in the electronic Trial Master File (eTMF)
  • Participate in development of subject recruitment/retention strategies ensuring patient enrollment and study timelines are maintained.  
  • Participate in the CRO/service provider selection process including defining the scope of work, transfer of obligations, budgets, timelines, and performance expectations.
  • With CTM guidance, plan and organize site training visits and investigators meetings.  
  • Support the coordination of operational and therapeutic area training for assigned team/CRO members, as applicable.
  • Participate in the build and specification testing for applicable IT systems (e.g. EDC, IVRS/IWRS, CTMS).

Study Conduct

  • Participate in CRO oversight of transferred obligations including study management, monitoring, site management, and TMF maintenance.
  • Assist in monitoring report review.
  • Support and correspond with sites to identify site specific needs (e.g. order and track study drug/other trial related supplies).
  • Provide input and support in the development and distribution of monthly site newsletters.
  • Assist in data collection/cleaning, line listing reviews, and data analysis at protocol specified timepoints.
  • Track the collection, shipping, accessing and analysis of biological samples and subject images as applicable.
  • Ensure inspection readiness is maintained for all trial activities throughout the study.
  • Other duties as assigned

Requirements:

  • At minimum, a bachelor’s degree in nursing, science or health related field required.
  • At least 2 years of clinical trial/clinical operations experience in a biotech organization or equivalent.
  • Experience with Oncology indications, Cell therapy experience highly desired.
  • Must be willing to travel 25-35% of time
  • Comfortable in a fast-paced, small company environment with ability to adjust workload based upon competing priorities

Manager, IT Global Business Applications

Instil Bio is seeking a Manager, IT Global Business Applications who will report to the Director, IT Global Business Applications and be responsible for helping the overall management and delivery of IT applications needed by Instilbio’s organizations (R&D, Clinical Development and Operations, Technical Operations, Pharmacovigilance, Regulatory, General and Administrative…). The ideal candidate will have excellent communication skills and a robust pharma/biotech IT experience. This position, located in Greater Los Angeles area, will directly interact with the business functions to align strategies, define robust IT roadmaps, manage expectations and ensure delivery.

Responsibilities may include, but are not limited to:

  • Understand and align with business strategies and priorities.
  • Contribute and maintain a robust IT roadmap of applications including definition of project objectives, prioritization, and implementation plans
  • Establish and foster relationships with Business Stakeholders and service providers
  • Evaluate vendor solutions, develop alternatives and recommend technical solutions in meeting the evolving needs of the business
  • Manage and be hands-on during execution of projects: scoping, requirements, documentation, testing, validation, training and support
  • Support and sustain deployed business applications
  • Create SOPs, Policies, Process and System maps for applications
  • Collaborate closely with Quality to ensure proper validation of applications where applicable (GxP standards)
  • Ensure compliance with various regulatory environments (SOX, GxP, EMA, GDPR, Privacy, HIPAA…)
  • Identify and analyze key technology trends that can be leveraged at Instilbio. In particular contribute to overall data strategy vision

Requirements, Knowledge, Skills and Abilities

  • Minimum of bachelor’s degree (Computer Science preferred) with at least 8 years of work experience and a minimum of 5 years in the Pharmaceutical/Biotechnology industry. Knowledge and background with a Cell & Gene Therapy company is a big plus
  • Understanding of both US and Global requirements (EU, UK, APAC) from an IT and compliance perspective
  • Experience working in a regulated environment (SOX, GxP, GDPR, HIPAA)
  • A strong background in software development methodology (i.e. Agile, SDLC, ITIL) and project management / business analysis
  • Proven application expertise relevant to business processes and functions across the value chain in a biotech company (from Research to Commercial)
  • Experience in defining and implementing IT strategies and technology roadmaps
  • Project management skills and strong focus on delivery
  • Experience with various applications such as ERP (Netsuite preferred), LIMS, MES, Veeva, LMS, HR, Supply Chain Planning, Reporting/Data mart
  • Ability to navigate from strategic to operational and hands-on with a sense of urgency and a solution-oriented filter
  • Strong interpersonal skills and excellent presentation and communication skills
  • Ability to communicate complex problems in a non-technical and simplified manner to stakeholders and end-users and to effectively communicate business needs to technology teams
  • Self-motivated with high degree of initiative and excellent follow-up skills, along with strong analytical and problem-solving skills
  • Comfortable in a fast-paced small company environment with minimal direction and changing priorities
  • Travel may be required

Associate Scientist/Senior Research Associate, Analytical Sciences

Instil Bio is looking for an Associate Scientist/Sr. Research Associate, Analytical Sciences in the Greater Los Angeles area.

The successful candidate will execute, troubleshoot, and support optimization of molecular biology assays utilizing qPCR/ddPCR. The individual will support the establishment of Analytical Sciences laboratory and execute assays to support method development and testing, transfer and regulatory filing activities. The individual will support successful lifecycle activities related to process and methods. The candidate will present data to colleagues and leadership and support manufacturing and analytical startup.

Skills/Knowledge:  B.S/M.S in immunology related fields or relevant life science degrees.  2+ years of experience in a relevant field. Familiarity with GMP, GLP and ICH guidelines. Ability to adapt and function in a dynamic and cross-functional environment.  Self-motivated, technically driven, and willing to take on duties outside of general role.  Excellent verbal, written, and presentation skills.  Ability to interpret and communicate relevant developments in academic literature. 

Scientist, Analytical Sciences

Instil Bio is looking for a Scientist, Analytical Sciences in the Greater Los Angeles area.

The successful candidate will be responsible for providing scientific and technical expertise and perform laboratory-based studies to develop, troubleshoot, qualify and transfer immunoassays, such as ELISA. The individual will support the establishment of Analytical Sciences laboratory to support testing, new technology evaluation and regulatory filing activities. The individual will support successful lifecycle activities related to process and methods. The candidate will author technical documents, present data to colleagues and leadership and support manufacturing and analytical startup. Occasional international travel may be required to support global sites.

Skills/Knowledge: MS or Ph.D in immunology related fields or relevant life science degrees.  4+ years of experience in a relevant field. Familiarity with GMP, GLP, ICH guidelines and biopharmaceutical regulations for various regulatory bodies, such as the FDA and EMA.  Background in cell therapy is preferred. Ability to adapt and function in a dynamic and cross-functional environment.  Self-motivated, technically driven, and willing to take on duties outside of general role.  Excellent verbal, written, and presentation skills.  Ability to interpret and communicate relevant developments in academic literature.  Creative thinking skills to challenge current understanding and help define process improvement and optimization opportunities. 

Sr. Research Associate/Research Associate, Analytical Sciences – Flow Cytometry

Instil Bio is looking for an Sr. Research Associate/Research Associate, Analytical Sciences in the Greater Los Angeles area.

The successful candidate will execute, troubleshoot and support optimization multi-parameter flow cytometry assays. The individual will support the establishment of Analytical Sciences laboratory and execute assays to support method development and testing, transfer and regulatory filing activities. The individual will support successful lifecycle activities related to process and methods. The candidate will present data to colleagues and leadership and support manufacturing and analytical startup.

Skills/Knowledge:  B.S. in immunology related fields or relevant life science degrees.  2+ years of experience in a relevant field. Familiarity with GMP, GLP and ICH guidelines. Ability to adapt and function in a dynamic and cross-functional environment.  Self-motivated, technically driven, and willing to take on duties outside of general role.  Excellent verbal, written, and presentation skills.  Ability to interpret and communicate relevant developments in academic literature. 

Scientist/Sr. Scientist, Analytical Sciences – T cell Potency

The Department of Analytical Sciences is seeking a Scientist/Sr. Scientist to lead the T cell Potency sub-team. This successful candidate and their team will take a biology-first approach to work cross-functionally with Discovery, Process Development, Quality and other key stakeholders to deliver T cell potency assays across oncology indications.

The successful candidate will be responsible for providing project and staff management as well as programmatic scientific and technical expertise. The candidate will also perform laboratory-based studies to develop, troubleshoot, qualify and transfer T cell potency assays across platforms. The individual will support the establishment of Analytical Sciences laboratory to support testing, new technology evaluation and regulatory filing activities. The individual will support successful lifecycle activities related to process and methods. The candidate will author technical documents, present data to colleagues and leadership and support manufacturing and analytical startup. Occasional international travel is required to support global sites. 

Location: This position is based in the Greater Los Angeles area. Skills/Knowledge: Ph.D in immunology related field or relevant life science degrees.  4+ years of experience in a relevant field. Familiarity with GMP, GLP, ICH guidelines and biopharmaceutical regulations for various regulatory bodies, such as the FDA and EMA.  Background in cell therapy is preferred. Ability to adapt and function in a dynamic and cross-functional environment.  Self-motivated, technically driven, and willing to take on duties outside of general role.  Excellent verbal, written, and presentation skills.  Ability to interpret and communicate relevant developments in academic literature.  Creative thinking skills to challenge current understanding and help define process improvement and optimization opportunities.   

Technician, QC Analytical

Instil Bio is looking for a highly motivated and driven individual to join us as a technician in the Quality Control organization. Initially as part of the start-up activities, you will be responsible for establishment and set-up of the QC testing laboratories in Tarzana area. As the site transitions into operation, you will primarily be responsible for providing technical expertise, testing and release of product, package material, raw material used in the production of Instil Bio’s cell therapy product.

Responsibilities (include but not limited to)

  • Responsible for receiving the raw materials from Vendors. Inspect and release the material for testing and distribute the materials to internal and external QC Labs
  • Perform testing of raw materials, intermediates and final products by following analytical and microbiological Compendial methods (pH, Osmolality, Conductivity etc)
  • Review final material packets and submit to QA for final disposition
  • Maintain internal and external test results, and work with internal departments on timely raw material release.
  • Maintain, calibrate and operate equipment and instruments in the QC laboratory
  • Order and maintain inventory of reagents and consumables in the QC laboratory
  • Monitor and trend data, complete routine record review of test data and related documents for raw materials and final product release.
  • If necessary, ship the materials to outside testing labs
  • Work independently with minimal supervision and ability to identify, effectively communicate, and troubleshoot issues.
  • Other duties may be assigned

Qualifications:

  • Associate Degree with 3+ years of experience or Bachelor Degree with 0+ year of experience
  • Experience with operating under GMP.
  • Ability to think critically and demonstrate troubleshooting/problem solving skills
  • Excellent skills in Microsoft Office, data analysis software, and other related applications
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Occasional weekends or holiday coverage required.

Senior QC Analyst/Analyst, QC Analytical

Instil Bio is looking for a highly motivated and experienced QC Senior analyst/Analyst in the Quality Control organization. Reporting to the Associate Director, Quality Control Analytical, you will be a hands-on resource for team. Initially as part of the start-up activities, you will be responsible for QC laboratory establishment and set-up and performing technical transfer including being trained on all the analytical assays. As the site transitions into operation, you will primarily be responsible for providing technical expertise, troubleshooting, training, and assay execution for analytical testing utilizing flow cytometry, ELISA, PCR, and cell-based bioassay. You will also contribute to the initiation and completion of quality records (i.e. investigation, deviation) associated with analytical testing at the site.

Responsibilities (include but not limited to)

  • Provide technical support for assay performance, training and troubleshooting of analytical issues in the context of a GMP laboratory.
  • Represent QC as a primary point of contact for analytical methods in collaboration with Manufacturing and Analytical Development organizations.
  • Author and revise processes and procedures for analytical method and associated work streams.
  • Establish processes and procedures for purchasing, implementation, training and maintaining QC equipment in collaboration with method subject matter experts.
  • Coordinate with stakeholders for equipment validation and manage validation activities in alignment with established timelines.
  • Responsibility for ensuring electronic data meets Part 11 requirements in alignment with internal procedures.
  • Lead teams to support deviations, investigations, CAPAs and change control activities as needed.
  • Support inspection readiness activities.
  • Participate in generating training module and instruction led training material
  • Other duties as required.

Qualifications:

  • Bachelor Degree with 1-3+ years of experience, preferably in a GMP environment or Master Degree with 0-1+ year of experience, preferably in a GMP environment.
  • Experience with flow cytometry, ddPCR, cell-based bioassays, and ELISA methodologies
  • Experience in cell therapy is preferred.
  • Experience with method qualification and transfer activities.
  • Experience in performing equipment validation activities.
  • Familiarity with FDA, EU, ICH and GMP guidelines.
  • Familiarity with Part 11 requirements.
  • Ability to think critically and demonstrate troubleshooting/problem solving skills.
  • Experience in conducting lab investigations, writing deviations, implementing CAPAs and initiating change controls.
  • Excellent skills in Microsoft Office, data analysis software, and other related applications.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Occasional weekends or holiday coverage is required.
  • Occasional international travel is required.

Senior TIL Recovery Specialist (Tampa)

ABOUT InstilBio
InstilBio Inc, a cell therapy company focused on solid tumors, has recently acquired Immetacyte Ltd. InstilBio is developing patient specific immunotherapies in oncology, allowing the patient’s
own immune system to be harnessed to fight cancer. The world-renowned team and its scientific advisors/investors have tremendous experience and track record in technology discovery, process
development, GMP manufacturing and clinical operations with a track record of developing and gaining approval for successful cell therapies.
We have built upon the expertise of researchers who have successfully undertaken scientific and clinical research alongside Professor Robert Hawkins. Professor Hawkins is a leader in the field
having undertaken several complex research projects and clinical trials involving: TIL, CAR-T, TCR based T cell therapies, cell selection, gene therapy, expansion of patient derived cells.
Recent significant investments in InstilBio are enabling the company to undertake Phase 2/3 to registrational clinical trials in melanoma. Further trials are planned in other solid tumor indications
and using gene-modified approaches to build a pipeline of TIL-based therapies.
Sr. TRS, HUB Lead/ Clinical Operations
Instil Bio is seeking a driven and experienced Sr. TIL Recovery Specialist. The successful candidate will be able to demonstrate and apply both theoretical and practical knowledge and skills as they
relate to TIL Recovery and work collaboratively with cross functional teams both internal and external to the Clinical Operations team.
The candidates must be knowledgeable of both GCP and GTP requirements.

This role will comprise multiple critical functions:

  • TIL Recovery
    • Tumor Procurement
    • TIL Procurement
  • Biomedical packaging, labeling, shipping LN2 dewars
  • HUB Quality Maintenance System
  • Inventory Management
  • Metrics
  • Maintain cGTP of HUB per 21 CFR 1271 in regard to:
    • Personnel
    • Procedures
    • Facilities
    • Environmental Controls and Monitoring
    • Equipment
    • Supplies and Reagents
    • Recovery
    • Labeling Controls
    • Records Maintenance and Appropriate Tracking
  • Conduct Training

The candidates must be knowledgeable of aseptic and sterile techniques, tissue handling, tissue procurement, reagent handling, labeling, basic logistics, basic anatomy.
In this role, the Sr. TIL Recovery Specialist will be expected to recover and transport tumor tissue from clinical institutions and regional hub to complete packaging and shipment of the tumor to manufacturing. Peripheral requirements of the role include management and oversight the assigned regional hub to meet all GCP/GTP requirements
This position will routinely interact with TIL Logistics Coordinators, Clinical Study Teams, Clinical Site Staff (Surgeon’s, OR Charge Nurses, OR Circulators, Surgical Technicians), and Couriers. This position will report to the TIL Recovery Specialist, Manager.


Responsibilities (include but not limited to):

  • Must maintain appropriate training standard and participate in refresher training as
  • appropriate.
  • Prepares and maintains all aspects of TIL Recovery:
    • Cleaning and disinfecting facilities before and after use per GTP requirements
    • Procurement
    • Packaging
    • Shipping TIL to the manufacturing sites
  • Maintains inventory of all supplies, consumables and media and keeps accurate documentation.
    • Receives supplies
    • Inspects supplies
    • Releases supplies
  • Will need to wear all appropriate personal protective equipment (PPE) as required.
  • Must adhere to aseptic technique, as required.
  • Trims, weighs, and splits a variety of tumor tissues as needed.
  • Communicates with TLCs on updates/statuses of TIL recovery process.
  • Communicates TIL recovery, packaging, and labeling requirements to clinical site staff.
  • Operationally supports TLCs during Dry Run preparation.
  • Participates in and provides TIL recovery updates at meetings as assigned.
  • Proactively identifies potential TIL recovery process issues/risks and
  • recommends/implements solutions.
  • Leads internal team meetings and provides training as necessary at hub meetings and other trial-specific meetings.
  • Manages the refinement and improvement of TIL recovery process.
  • Creates and manages TIL recovery programs as assigned, programs of which pertain to hub maintenance & TIL recovery.
  • Provides oversight of TIL recovery training.
  • Participates in the development, review, and implementation of departmental SOPs and processes.
  • Ensures audit and inspection readiness of assigned tissue recovery hub.
  • Prepares and presents metrics and updates for management as assigned.
  • Attends external/internal cross-functional meetings as assigned.
  • Participates in 24/7 on-call response program.
  • 50-70% travel required
  • May culture environment and tissues to monitor contamination rates.
  • May be required to work outside of normal business hours in support of TIL recovery and processing activities.
  • May assist with low-level management responsibilities as assigned.
  • May be required to prepare media, sterilize instruments, and use laminar flow hood for processing.

Requirements and Recommendations:
• Associate’s degree in surgical tech with 8 years of work experience as surgical tech,
tissue, organ recovery or processing or related field in tissue/organ recovery or
processing preferred
OR
• BS or BA in a relevant scientific discipline with 6 years of work experience as surgical
tech, tissue, organ recovery or processing or related field in tissue/organ recovery or
processing preferred
OR
• MS/MA in a relevant discipline with 4 years of work experience as surgical tech, tissue,
organ recovery or processing or related field in tissue/organ recovery or processing
preferred

It is critical that you have:
o Basic understanding of Anatomy
o Previous Tissue Recovery experience
OR
o Previous Surgical Technician experience
o Valid driver’s license, registration, and insurance
o Own means of transportation
o Excellent time management skills
o Excellent interpersonal ability
• It is strongly encouraged that this role has:
o Certified Eye Bank Technician (CEBT)
o Certified Tissue Banking Specialist (CTBS)
o Certified Surgical Technician
o Knowledge of FDA regulations as applied to Human Cells, Tissues, and Cellular and
Tissue-Based Products
o Knowledge of HTA regulations
• Personal Skills:
o Dexterity
o Microsoft Office Suite
o Strong Communication & Presentation Skills

Senior TIL Recovery Specialist (Boston)

ABOUT InstilBio
InstilBio Inc, a cell therapy company focused on solid tumors, has recently acquired Immetacyte Ltd. InstilBio is developing patient specific immunotherapies in oncology, allowing the patient’s
own immune system to be harnessed to fight cancer. The world-renowned team and its scientific advisors/investors have tremendous experience and track record in technology discovery, process
development, GMP manufacturing and clinical operations with a track record of developing and gaining approval for successful cell therapies.
We have built upon the expertise of researchers who have successfully undertaken scientific and clinical research alongside Professor Robert Hawkins. Professor Hawkins is a leader in the field
having undertaken several complex research projects and clinical trials involving: TIL, CAR-T, TCR based T cell therapies, cell selection, gene therapy, expansion of patient derived cells.
Recent significant investments in InstilBio are enabling the company to undertake Phase 2/3 to registrational clinical trials in melanoma. Further trials are planned in other solid tumor indications
and using gene-modified approaches to build a pipeline of TIL-based therapies.
Sr. TRS, HUB Lead/ Clinical Operations
Instil Bio is seeking a driven and experienced Sr. TIL Recovery Specialist. The successful candidate will be able to demonstrate and apply both theoretical and practical knowledge and skills as they
relate to TIL Recovery and work collaboratively with cross functional teams both internal and external to the Clinical Operations team.
The candidates must be knowledgeable of both GCP and GTP requirements.

This role will comprise multiple critical functions:

  • TIL Recovery
    • Tumor Procurement
    • TIL Procurement
  • Biomedical packaging, labeling, shipping LN2 dewars
  • HUB Quality Maintenance System
  • Inventory Management
  • Metrics
  • Maintain cGTP of HUB per 21 CFR 1271 in regard to:
    • Personnel
    • Procedures
    • Facilities
    • Environmental Controls and Monitoring
    • Equipment
    • Supplies and Reagents
    • Recovery
    • Labeling Controls
    • Records Maintenance and Appropriate Tracking
  • Conduct Training

The candidates must be knowledgeable of aseptic and sterile techniques, tissue handling, tissue procurement, reagent handling, labeling, basic logistics, basic anatomy.
In this role, the Sr. TIL Recovery Specialist will be expected to recover and transport tumor tissue from clinical institutions and regional hub to complete packaging and shipment of the tumor to manufacturing. Peripheral requirements of the role include management and oversight the assigned regional hub to meet all GCP/GTP requirements
This position will routinely interact with TIL Logistics Coordinators, Clinical Study Teams, Clinical Site Staff (Surgeon’s, OR Charge Nurses, OR Circulators, Surgical Technicians), and Couriers. This position will report to the TIL Recovery Specialist, Manager.


Responsibilities (include but not limited to):

  • Must maintain appropriate training standard and participate in refresher training as
  • appropriate.
  • Prepares and maintains all aspects of TIL Recovery:
    • Cleaning and disinfecting facilities before and after use per GTP requirements
    • Procurement
    • Packaging
    • Shipping TIL to the manufacturing sites
  • Maintains inventory of all supplies, consumables and media and keeps accurate documentation.
    • Receives supplies
    • Inspects supplies
    • Releases supplies
  • Will need to wear all appropriate personal protective equipment (PPE) as required.
  • Must adhere to aseptic technique, as required.
  • Trims, weighs, and splits a variety of tumor tissues as needed.
  • Communicates with TLCs on updates/statuses of TIL recovery process.
  • Communicates TIL recovery, packaging, and labeling requirements to clinical site staff.
  • Operationally supports TLCs during Dry Run preparation.
  • Participates in and provides TIL recovery updates at meetings as assigned.
  • Proactively identifies potential TIL recovery process issues/risks and
  • recommends/implements solutions.
  • Leads internal team meetings and provides training as necessary at hub meetings and other trial-specific meetings.
  • Manages the refinement and improvement of TIL recovery process.
  • Creates and manages TIL recovery programs as assigned, programs of which pertain to hub maintenance & TIL recovery.
  • Provides oversight of TIL recovery training.
  • Participates in the development, review, and implementation of departmental SOPs and processes.
  • Ensures audit and inspection readiness of assigned tissue recovery hub.
  • Prepares and presents metrics and updates for management as assigned.
  • Attends external/internal cross-functional meetings as assigned.
  • Participates in 24/7 on-call response program.
  • 50-70% travel required
  • May culture environment and tissues to monitor contamination rates.
  • May be required to work outside of normal business hours in support of TIL recovery and processing activities.
  • May assist with low-level management responsibilities as assigned.
  • May be required to prepare media, sterilize instruments, and use laminar flow hood for processing.

Requirements and Recommendations:
• Associate’s degree in surgical tech with 8 years of work experience as surgical tech,
tissue, organ recovery or processing or related field in tissue/organ recovery or
processing preferred
OR
• BS or BA in a relevant scientific discipline with 6 years of work experience as surgical
tech, tissue, organ recovery or processing or related field in tissue/organ recovery or
processing preferred
OR
• MS/MA in a relevant discipline with 4 years of work experience as surgical tech, tissue,
organ recovery or processing or related field in tissue/organ recovery or processing
preferred

It is critical that you have:
o Basic understanding of Anatomy
o Previous Tissue Recovery experience
OR
o Previous Surgical Technician experience
o Valid driver’s license, registration, and insurance
o Own means of transportation
o Excellent time management skills
o Excellent interpersonal ability
• It is strongly encouraged that this role has:
o Certified Eye Bank Technician (CEBT)
o Certified Tissue Banking Specialist (CTBS)
o Certified Surgical Technician
o Knowledge of FDA regulations as applied to Human Cells, Tissues, and Cellular and
Tissue-Based Products
o Knowledge of HTA regulations
• Personal Skills:
o Dexterity
o Microsoft Office Suite
o Strong Communication & Presentation Skills

Senior TIL Recovery Specialist (Thousand Oaks)

ABOUT InstilBio
InstilBio Inc, a cell therapy company focused on solid tumors, has recently acquired Immetacyte Ltd. InstilBio is developing patient specific immunotherapies in oncology, allowing the patient’s
own immune system to be harnessed to fight cancer. The world-renowned team and its scientific advisors/investors have tremendous experience and track record in technology discovery, process
development, GMP manufacturing and clinical operations with a track record of developing and gaining approval for successful cell therapies.
We have built upon the expertise of researchers who have successfully undertaken scientific and clinical research alongside Professor Robert Hawkins. Professor Hawkins is a leader in the field
having undertaken several complex research projects and clinical trials involving: TIL, CAR-T, TCR based T cell therapies, cell selection, gene therapy, expansion of patient derived cells.
Recent significant investments in InstilBio are enabling the company to undertake Phase 2/3 to registrational clinical trials in melanoma. Further trials are planned in other solid tumor indications
and using gene-modified approaches to build a pipeline of TIL-based therapies.
Sr. TRS, HUB Lead/ Clinical Operations
Instil Bio is seeking a driven and experienced Sr. TIL Recovery Specialist. The successful candidate will be able to demonstrate and apply both theoretical and practical knowledge and skills as they
relate to TIL Recovery and work collaboratively with cross functional teams both internal and external to the Clinical Operations team.
The candidates must be knowledgeable of both GCP and GTP requirements.

This role will comprise multiple critical functions:

  • TIL Recovery
    • Tumor Procurement
    • TIL Procurement
  • Biomedical packaging, labeling, shipping LN2 dewars
  • HUB Quality Maintenance System
  • Inventory Management
  • Metrics
  • Maintain cGTP of HUB per 21 CFR 1271 in regard to:
    • Personnel
    • Procedures
    • Facilities
    • Environmental Controls and Monitoring
    • Equipment
    • Supplies and Reagents
    • Recovery
    • Labeling Controls
    • Records Maintenance and Appropriate Tracking
  • Conduct Training

The candidates must be knowledgeable of aseptic and sterile techniques, tissue handling, tissue procurement, reagent handling, labeling, basic logistics, basic anatomy.
In this role, the Sr. TIL Recovery Specialist will be expected to recover and transport tumor tissue from clinical institutions and regional hub to complete packaging and shipment of the tumor to manufacturing. Peripheral requirements of the role include management and oversight the assigned regional hub to meet all GCP/GTP requirements
This position will routinely interact with TIL Logistics Coordinators, Clinical Study Teams, Clinical Site Staff (Surgeon’s, OR Charge Nurses, OR Circulators, Surgical Technicians), and Couriers. This position will report to the TIL Recovery Specialist, Manager.


Responsibilities (include but not limited to):

  • Must maintain appropriate training standard and participate in refresher training as
  • appropriate.
  • Prepares and maintains all aspects of TIL Recovery:
    • Cleaning and disinfecting facilities before and after use per GTP requirements
    • Procurement
    • Packaging
    • Shipping TIL to the manufacturing sites
  • Maintains inventory of all supplies, consumables and media and keeps accurate documentation.
    • Receives supplies
    • Inspects supplies
    • Releases supplies
  • Will need to wear all appropriate personal protective equipment (PPE) as required.
  • Must adhere to aseptic technique, as required.
  • Trims, weighs, and splits a variety of tumor tissues as needed.
  • Communicates with TLCs on updates/statuses of TIL recovery process.
  • Communicates TIL recovery, packaging, and labeling requirements to clinical site staff.
  • Operationally supports TLCs during Dry Run preparation.
  • Participates in and provides TIL recovery updates at meetings as assigned.
  • Proactively identifies potential TIL recovery process issues/risks and
  • recommends/implements solutions.
  • Leads internal team meetings and provides training as necessary at hub meetings and other trial-specific meetings.
  • Manages the refinement and improvement of TIL recovery process.
  • Creates and manages TIL recovery programs as assigned, programs of which pertain to hub maintenance & TIL recovery.
  • Provides oversight of TIL recovery training.
  • Participates in the development, review, and implementation of departmental SOPs and processes.
  • Ensures audit and inspection readiness of assigned tissue recovery hub.
  • Prepares and presents metrics and updates for management as assigned.
  • Attends external/internal cross-functional meetings as assigned.
  • Participates in 24/7 on-call response program.
  • 50-70% travel required
  • May culture environment and tissues to monitor contamination rates.
  • May be required to work outside of normal business hours in support of TIL recovery and processing activities.
  • May assist with low-level management responsibilities as assigned.
  • May be required to prepare media, sterilize instruments, and use laminar flow hood for processing.

Requirements and Recommendations:
• Associate’s degree in surgical tech with 8 years of work experience as surgical tech,
tissue, organ recovery or processing or related field in tissue/organ recovery or
processing preferred
OR
• BS or BA in a relevant scientific discipline with 6 years of work experience as surgical
tech, tissue, organ recovery or processing or related field in tissue/organ recovery or
processing preferred
OR
• MS/MA in a relevant discipline with 4 years of work experience as surgical tech, tissue,
organ recovery or processing or related field in tissue/organ recovery or processing
preferred

It is critical that you have:
o Basic understanding of Anatomy
o Previous Tissue Recovery experience
OR
o Previous Surgical Technician experience
o Valid driver’s license, registration, and insurance
o Own means of transportation
o Excellent time management skills
o Excellent interpersonal ability
• It is strongly encouraged that this role has:
o Certified Eye Bank Technician (CEBT)
o Certified Tissue Banking Specialist (CTBS)
o Certified Surgical Technician
o Knowledge of FDA regulations as applied to Human Cells, Tissues, and Cellular and
Tissue-Based Products
o Knowledge of HTA regulations
• Personal Skills:
o Dexterity
o Microsoft Office Suite
o Strong Communication & Presentation Skills

Senior TIL Recovery Specialist (Philadelphia)

ABOUT InstilBio
InstilBio Inc, a cell therapy company focused on solid tumors, has recently acquired Immetacyte Ltd. InstilBio is developing patient specific immunotherapies in oncology, allowing the patient’s
own immune system to be harnessed to fight cancer. The world-renowned team and its scientific advisors/investors have tremendous experience and track record in technology discovery, process
development, GMP manufacturing and clinical operations with a track record of developing and gaining approval for successful cell therapies.
We have built upon the expertise of researchers who have successfully undertaken scientific and clinical research alongside Professor Robert Hawkins. Professor Hawkins is a leader in the field
having undertaken several complex research projects and clinical trials involving: TIL, CAR-T, TCR based T cell therapies, cell selection, gene therapy, expansion of patient derived cells.
Recent significant investments in InstilBio are enabling the company to undertake Phase 2/3 to registrational clinical trials in melanoma. Further trials are planned in other solid tumor indications
and using gene-modified approaches to build a pipeline of TIL-based therapies.
Sr. TRS, HUB Lead/ Clinical Operations
Instil Bio is seeking a driven and experienced Sr. TIL Recovery Specialist. The successful candidate will be able to demonstrate and apply both theoretical and practical knowledge and skills as they
relate to TIL Recovery and work collaboratively with cross functional teams both internal and external to the Clinical Operations team.
The candidates must be knowledgeable of both GCP and GTP requirements.

This role will comprise multiple critical functions:

  • TIL Recovery
    • Tumor Procurement
    • TIL Procurement
  • Biomedical packaging, labeling, shipping LN2 dewars
  • HUB Quality Maintenance System
  • Inventory Management
  • Metrics
  • Maintain cGTP of HUB per 21 CFR 1271 in regard to:
    • Personnel
    • Procedures
    • Facilities
    • Environmental Controls and Monitoring
    • Equipment
    • Supplies and Reagents
    • Recovery
    • Labeling Controls
    • Records Maintenance and Appropriate Tracking
  • Conduct Training

The candidates must be knowledgeable of aseptic and sterile techniques, tissue handling, tissue procurement, reagent handling, labeling, basic logistics, basic anatomy.
In this role, the Sr. TIL Recovery Specialist will be expected to recover and transport tumor tissue from clinical institutions and regional hub to complete packaging and shipment of the tumor to manufacturing. Peripheral requirements of the role include management and oversight the assigned regional hub to meet all GCP/GTP requirements
This position will routinely interact with TIL Logistics Coordinators, Clinical Study Teams, Clinical Site Staff (Surgeon’s, OR Charge Nurses, OR Circulators, Surgical Technicians), and Couriers. This position will report to the TIL Recovery Specialist, Manager.


Responsibilities (include but not limited to):

  • Must maintain appropriate training standard and participate in refresher training as
  • appropriate.
  • Prepares and maintains all aspects of TIL Recovery:
    • Cleaning and disinfecting facilities before and after use per GTP requirements
    • Procurement
    • Packaging
    • Shipping TIL to the manufacturing sites
  • Maintains inventory of all supplies, consumables and media and keeps accurate documentation.
    • Receives supplies
    • Inspects supplies
    • Releases supplies
  • Will need to wear all appropriate personal protective equipment (PPE) as required.
  • Must adhere to aseptic technique, as required.
  • Trims, weighs, and splits a variety of tumor tissues as needed.
  • Communicates with TLCs on updates/statuses of TIL recovery process.
  • Communicates TIL recovery, packaging, and labeling requirements to clinical site staff.
  • Operationally supports TLCs during Dry Run preparation.
  • Participates in and provides TIL recovery updates at meetings as assigned.
  • Proactively identifies potential TIL recovery process issues/risks and
  • recommends/implements solutions.
  • Leads internal team meetings and provides training as necessary at hub meetings and other trial-specific meetings.
  • Manages the refinement and improvement of TIL recovery process.
  • Creates and manages TIL recovery programs as assigned, programs of which pertain to hub maintenance & TIL recovery.
  • Provides oversight of TIL recovery training.
  • Participates in the development, review, and implementation of departmental SOPs and processes.
  • Ensures audit and inspection readiness of assigned tissue recovery hub.
  • Prepares and presents metrics and updates for management as assigned.
  • Attends external/internal cross-functional meetings as assigned.
  • Participates in 24/7 on-call response program.
  • 50-70% travel required
  • May culture environment and tissues to monitor contamination rates.
  • May be required to work outside of normal business hours in support of TIL recovery and processing activities.
  • May assist with low-level management responsibilities as assigned.
  • May be required to prepare media, sterilize instruments, and use laminar flow hood for processing.

Requirements and Recommendations:
• Associate’s degree in surgical tech with 8 years of work experience as surgical tech,
tissue, organ recovery or processing or related field in tissue/organ recovery or
processing preferred
OR
• BS or BA in a relevant scientific discipline with 6 years of work experience as surgical
tech, tissue, organ recovery or processing or related field in tissue/organ recovery or
processing preferred
OR
• MS/MA in a relevant discipline with 4 years of work experience as surgical tech, tissue,
organ recovery or processing or related field in tissue/organ recovery or processing
preferred

It is critical that you have:
o Basic understanding of Anatomy
o Previous Tissue Recovery experience
OR
o Previous Surgical Technician experience
o Valid driver’s license, registration, and insurance
o Own means of transportation
o Excellent time management skills
o Excellent interpersonal ability
• It is strongly encouraged that this role has:
o Certified Eye Bank Technician (CEBT)
o Certified Tissue Banking Specialist (CTBS)
o Certified Surgical Technician
o Knowledge of FDA regulations as applied to Human Cells, Tissues, and Cellular and
Tissue-Based Products
o Knowledge of HTA regulations
• Personal Skills:
o Dexterity
o Microsoft Office Suite
o Strong Communication & Presentation Skills

Manager, Clinical Trials

Instil Bio is a global clinical-stage biotechnology company focused on the development of novel immuno-oncology treatments called tumor infiltrating lymphocytes (TILs). TILs are naturally occurring immune cells that have the ability to identify and destroy cancer cells. Instil Bio is engineering TILs to harness and amplify their cancer fighting ability to treat of a broad range of solid tumor cancers.  Instil Bio is located in southern California with additional manufacturing and research facilities in Manchester U.K.

Instil Bio is seeking a Global Clinical Trial Manager (CTM) responsible for managing all aspects of clinical trial conduct beginning with study start-up through trial close-out. The CTM will also forecast and manage all resources, timelines, and budgets associated with assigned trials. The position will report to the Vice President of Clinical Operations.

Responsibilities include but, are not limited to:

Leadership

  • Oversee all stages of trial conduct beginning with study design, study start-up, patient enrollment, study conduct, and trial close-out.
  • Provides leadership to the clinical operations team ensuring study goals are delivered on time, on budget, and with a high degree of quality.
  • Organize and manage study team meetings including agendas, meeting minutes, assignment of tasks, and resolution of outstanding items.
  • Participates in the selection, training, and management of study personnel.
  • Anticipate complex obstacles and proactively implement solutions to achieve study goals.
  • Prepare trial metrics and provide study progress reports to executive management.
  • Interact with cross functional departments (i.e., Clinical Development, Biometrics, Regulatory Affairs, Safety, Translational Sciences, and Clinical Supply Chain etc.)
  • Ensure trial activities are in compliance with Code of Federal Regulations (CFR), ICH/GCP guidelines, local regulatory requirements, and company SOPs
  • Participate in the development, review and implementation of department SOPs/processes

Study Design & Study Start-Up

  • Draft and coordinate the review of trial related documents including protocols, informed consent forms, case report forms, study conduct plans, and clinical study reports.
  • Facilitate country and site feasibility to identify and recruit clinical investigators.
  • Partner with contracts department on the development of site budget, CTA templates and negotiations
  • Oversee the collection of essential documents necessary for site activation. 
  • Develop subject recruitment/retention strategies ensuring patient enrollment and study timelines are maintained.  
  • Participate in the CRO/service provider selection process including defining the scope of work, transfer of obligations, budgets, timelines, and performance expectations.
  • Plan, organize and oversee site training visits and investigators meetings.  
  • Coordinate operational and therapeutic area training for assigned team/CRO members.
  • In collaboration with clinical logistics, ensure proper shipping, management, and administration of cell therapy products including labeling and IP accountability as applicable.
  • Participate in the build and specification testing for applicable IT systems (e.g. EDC, IVRS/IWRS, CTMS).
  • Perform risk assessments to identify potential study issues and develop mitigation strategies and contingency planning to minimize risk occurrence.

Study Conduct

  • Provide oversight of CRO interactions for transferred obligations including study management, monitoring, site management, and TMF maintenance.
  • Conduct study monitoring visits and co-monitoring visits as required.
  • Support and correspond with sites to address site specific study needs.
  • Oversees data collection/cleaning, line listing reviews, and data analysis at protocol specified timepoints.
  • Prepare for and schedule DSMB interactions and attend meetings as applicable.
  • Ensure inspection readiness is maintained for all trial activities throughout the study.
  • Other duties as assigned

Requirements:

  • At minimum, a bachelor’s degree in nursing, science or health related field required.
  • At least 4-6 years of clinical trial/clinical operations experience in a biotech organization or equivalent.
  • Experience with Oncology indications, Cell therapy experience highly desired.
  • Highly developed leadership skills to successfully lead a clinical study team 
  • Must be willing to travel 25-35% of time
  • Ability to deal with time demands, incomplete information or unexpected events
  • Must display strong analytical and problem-solving skills. Attention to detail required
  • Outstanding organizational skills with the ability to multi-task and prioritize
  • Excellent interpersonal, verbal and written communication skills 
  • Comfortable in a fast-paced, small company environment with ability to adjust workload based upon competing priorities

Senior Manager, Quality Systems

Sr. Manager, Quality Systems

Instil Bio is seeking a driven and experienced Sr. Manager, Quality Systems.  The successful candidate will be a quality professional with experience developing, implementing, and maintaining Quality System processes.    

The candidates must be knowledgeable of Quality Management Systems, including but not limited to Document Management, Deviations and CAPAs, Change Control, Training, etc.  

In this role, the Sr. Manager, Quality Systems will manage the development, implementation, and maintenance of Quality Systems, policies, processes, procedures, and controls to ensure compliance to cGMP/GxP documentation and established regulatory standards. 

This position will routinely interact with other Quality Assurance functions, Quality Control, Manufacturing, MSAT, Engineering/Facilities.  This position will report to the Director, Quality Assurance. 

Responsibilities (include but not limited to):

  • Develop, implement, and maintain phase-appropriate quality systems including documentation management, deviations, CAPA, change control, training, and auditing
  • Develop and establish SOPs taking into consideration risk-based approach
  • Provide support and serve as site Subject Matter Expert on Quality Systems during audits and regulatory inspections
  • Analyze, interpret, or disseminate system performance data (e.g., KPI and site metrics)
  • Provide oversight and/or approve QMS records per applicable procedures 
  • Review documents, protocols, and reports from quality perspective for adherence to applicable regulations
  • Mentor Document owners, Investigators, Change Owners, Quality Approvers, and Action Owners
  • Provide leadership, guidance, and training to cross-functional teams
  • Grant, revise, and revoke system access, as necessary
  • Oversee Quality Systems operating mechanisms (e.g. Change Control Review Board (CCB), etc.)
  • Lead/assist with audit/inspection readiness activities
  • Participate/lead and provide QA input to cross-functional teams to evaluate and ensure timely & proper closure of deviations, investigations, complaints, change controls and CAPAs
  • Identify, implement, and provide leadership for continuous improvement projects/initiatives
  • Hire and manage staff to support the department
  • Manage department budget
  • Complete other responsibilities, as assigned

Requirements and Recommendations:

  • Bachelor’s Degree in Sciences, Engineering, or related field
  • Minimum of 8 years of progressive Quality experience in a GMP environment (biotechnology, pharmaceutical, and/or cell therapy operations)
  • It is critical that you have:
    • Strong working knowledge and experience of GxP regulations, quality systems, and regulatory guidance documents in US and EU
    • Expert knowledge of electronically based Quality Systems
    • Ability to interpret and relate quality standards for implementation
    • Knowledge and experience in biotech/pharmaceutical Quality Systems
    • Clinical manufacturing and/or commercial manufacturing experience
  • It is strongly encouraged that this role have:
    • Understanding and experience of cell therapy processes
    • Facility start-up experience
  • Personal Skills:
    • Demonstrated problem-solving and critical thinking skills
    • Strong courage of conviction and conflict resolution skills
    • Ability to work effectively in a dynamic, complex, and fast paced team environment
    • Self-motivated, technically driven, and willing to take on duties outside of general responsibilities
    • Excellent interpersonal, verbal, and written communication skills
    • Excellent leader with strong coaching and mentoring skills
    • Demonstrated ability to multi-task effectively and adjust workload based on changing priorities
    • Ability to work independently and with minimal supervision
    • Demonstrated problem-solving and critical thinking skills
    • Demonstrated organizational skills
    • Demonstrated ability to train and mentor others
    • Strong presentation skills to all levels of organization

Manager/Senior Manager, Quality Operations

Instil Bio is seeking a driven and experienced Quality Operations Manager/Sr. Manager.  The successful candidate will have proven leadership in supporting manufacturing operations in a fast-paced environment and apply risk-based, phased-appropriate, and timely implementation of actions.   

The candidates must be knowledgeable of batch record review, lot disposition requirements, quality systems workflow and approval requirements, GxP and regulatory standards.

In this role, the Manager/Sr. Manager will be expected to provide QA oversight and leadership to ensure timely disposition of product per applicable GxP standards/regulations.  

This position will routinely interact with other Quality Assurance functions, Quality Control, Manufacturing, Supply Chain, Engineering/Facilities.  This position will report to the Director, Quality Assurance.

Responsibilities (include but not limited to):

  • Implement cGMP QA Operations procedures to support clinical and commercial manufacturing
  • Provide day-to-day Quality oversight of cGMP activities for manufacturing, labeling, batch record review and lot disposition (including raw materials)
  • Provide support for deviations, non-conforming events, laboratory out-of-specifications, and corrective action/preventative action investigations
  • Provide support for change controls  
  • Responsible for compliance with current regulatory or product requirements and cGMPs,
  • Review documents, protocols, and reports from quality perspective for adherence to applicable regulations
  • Develop and establish SOPs taking into consideration risk-based approach
  • Collaborate cross-functionally (e.g., Manufacturing, Regulatory, QC, other QA areas) to ensure product is manufactured according to approved procedures and complies with applicable regulations
  • Hire and manage staff to support the department
  • Lead and mentor the Quality Operations Team
  • Ensure knowledge sharing and collaborative troubleshooting and problem solving
  • Act as subject matter expert for Quality Operations during audits and regulatory inspections
  • Implement continuous improvement projects
  • Manage department budget
  • Complete other responsibilities, as assigned

Requirements and Recommendations:

  • Bachelor’s degree in Sciences, Engineering, or related field   
  • 5-8 years Quality Assurance experience in a GMP environment (biotechnology, pharmaceutical, and/or cell therapy operations)
  • It is critical that you have:
    • Strong working knowledge and experience of GxP regulations, quality systems, and regulatory guidance documents in US and EU
    • Experience in lot disposition (raw material and product) and quality systems (e.g., deviations, CAPAs, change control, training, complaint handling)
    • Experience working and direct interface with regulatory agencies
    • Ability to work in controlled & classified environment requiring donning of cleanroom garments (e.g., gowns, gloves, booties, hoods/masks, etc.)
    • Clinical manufacturing and/or commercial manufacturing experience
  • It is strongly encouraged that this role have:
    • Understanding and experience of cell therapy processes
    • Knowledge/experience in aseptic manufacturing processes and procedure  
  • Personal Skills:
    • Demonstrated problem-solving and critical thinking skills
    • Strong courage of conviction and conflict resolution skills
    • Ability to work effectively in a dynamic, complex, and fast paced team environment
    • Excellent interpersonal, verbal, and written communication skills
    • Excellent leader with strong coaching and mentoring skills
    • Demonstrated ability to multi-task effectively and adjust workload based on changing priorities
    • Self-motivated, technically driven, and willing to take on duties outside of general responsibilities

Senior Manager/Associate Director, Supplier Quality

Instil Bio is seeking a driven and experienced Sr. Manager/Associate Director, Supplier Quality.  The successful candidate will be a highly motivated hands-on leader who has experience in Supplier Quality and implementation of the SQ principles, procedures, and processes including risk identification, evaluation, and management. 

The candidates must be knowledgeable of vendor, supplier and material management process and systems.

In this role, the Sr. Manager/Associate Director, Supplier Quality will be expected to own and manage the Supplier Quality management program, develop and execute strategic direction and oversight pertaining to external auditing and supplier quality, and collaborate and drive cross-functionally to execute the SQM program.    

This position will routinely interact with Quality, Supply Chain, Procurement, Manufacturing.  This position will report to the Sr. Director, Quality. 

Responsibilities (include but not limited to):

  • Manage the development, deployment, and maintenance of the Supplier Quality program
  • Accountable for the supplier compliance of Audits, Supplier Quality Agreements (SQA), SCARs, Supplier Questionnaires, Supplier Request for Information, and management of supplier-initiated changes, including:
    • Supplier qualification and specification development processes using phased appropriate, risk-based tools for qualification, classification, and performance monitoring
    • Quality Agreements to assure key quality expectations are reflected in the supplier’s operations and updates for changes are managed  
  • Conduct supplier audits (Develop plan, prepare reports, communicate findings, audit responses, compliance assessment outcome)
  • Maintain approved supplier list
  • Monitor and report on meaningful SQM performance metrics (KPI) as well as Supplier performance metrics
  • Collaborate with cross-functional stakeholders on matters pertaining to supplier controls, significant concerns related to Quality system performance, risk-based audit execution, issue escalation, procurement strategy and regulatory compliance  
  • Participate as a representative of SQM on project teams
  • Assure all SQM related quality documentation and records are completed thoroughly and timely to maintain compliance
  • Support inspection readiness plans and interact with regulatory agencies during inspections on SQM-related matters, as needed
  • Hire, manage, develop, coach, and mentor staff
  • Implement continuous improvement projects
  • Manage department budget
  • Complete other responsibilities, as assigned

Requirements and Recommendations:

  • Bachelor’s degree in a scientific discipline
  • 8-10 years Quality/Supplier Quality experience in a GMP environment (biotechnology, pharmaceutical, and/or cell therapy operations)
  • Travel may be required, up to 20 % (domestic and international)
  • It is critical that you have:
    • Experience across multiple Quality areas (QA, QC, Systems and Compliance
    • In-depth knowledge of and ability to apply GMP in conformance to the US and EU
    • Experience working and direct interface with regulatory agencies
    • Experience writing, evaluating, and closing investigations, CAPAs and change control records
    • In-depth understanding with vendor, supplier and material management process and systems
    • Experience with Quality Risk Management principles
    • Good technical report writing skills
  • It is strongly encouraged that this role have:
    • ASQ’s Certified Supplier Quality Professional (CSQP)
    • PMP certification
    • Understanding and experience of cell therapy processes
    • Facility start-up or quality systems/SQM implementation experience
  • Personal Skills:
    • Excellent critical thinking, analytical, and problem-solving skills
    • Excellent interpersonal, influencing, verbal, and written communication skills
    • Strong courage of conviction and conflict resolution skills
    • Ability to work effectively in a dynamic, complex, and fast paced team environment
    • Demonstrated ability to multi-task effectively and adjust workload based on changing priorities
    • Strong demonstrated strategic thinking capability

QA Senior Specialist, Quality Systems

Instil Bio is seeking a driven and experienced QA Sr. Specialist, Quality Systems.  The successful candidate will be a quality professional with extensive Quality Systems experience and be responsible for providing technical expertise and review/approval of Quality System processes and documentation. 

The candidates must be knowledgeable of Quality Management Systems, including but not limited to Document Management, Deviations and CAPAs, Change Control, Training, etc.  

In this role, the QA Sr. Specialist, Quality Systems will facilitate the Quality Systems processes, provide technical support on Quality Systems standards and processes to team members as an SME, and implement continuous improvement within QS processes.

This position will routinely interact with other Quality Assurance functions, Quality Control, Manufacturing, MSAT, Engineering/Facilities.  This position will report to the Sr. Manager, Quality Systems.

Responsibilities (include but not limited to):

  • Participate in the development, implementation, and maintenance of processes and procedures supporting Quality Management System (QMS)
  • Administer, facilitate, and maintain site quality management systems (e.g., Document management, Deviations/CAPAs, Change Control, Training)
  • Serve as site SME and support for Quality System related activities and participates in audits and regulatory inspections
  • Prepare, maintain, and report data for KPI and site metrics
  • Interface with cross-functional teams to resolve Quality Systems related issues
  • Provide oversight and/or directly manage and/or approve QMS records per applicable procedures 
  • Mentor Document owners, Investigators, Change Owners, Quality Approvers, and Action Owners
  • Provide training for site staff involved in Quality System processes. 
  • Grant, revise, and revoke system access, as necessary. 
  • Lead and/or actively participate in Quality Systems operating mechanisms (e.g. Change Control Review Board (CCB), etc.)
  • Lead/assist with audit/inspection readiness activities
  • Provide guidance and assist users with QA System workflow management
  • Provide QA input to functional groups to evaluate and ensure timely & proper closure of deviations, investigations, complaints, change controls and CAPAs
  • Implement continuous improvement projects
  • Complete other responsibilities, as assigned

Requirements and Recommendations:

  • Bachelor’s Degree in Sciences, Engineering, or related field
  • Minimum of 7 years of progressive Quality and/or Manufacturing experience in a GMP environment (biotechnology, pharmaceutical, and/or cell therapy operations)
  • It is critical that you have:
    • Solid knowledge of cGMP
    • Ability to interpret and relate quality standards for implementation
    • Knowledge and experience in a highly regulated manufacturing environment
    • Knowledge and experience in biotech/pharmaceutical Quality Systems
  • It is strongly encouraged that this role have:
    • Understanding and experience of cell therapy processes
    • Facility start-up or quality systems implementation experience
  • Personal Skills:
    • Self-motivated, technically driven, and willing to take on duties outside of general responsibilities
    • Excellent interpersonal, verbal, and written communication skills
    • Demonstrated ability to multi-task effectively and adjust workload based on changing priorities
    • Ability to work independently and with minimal supervision
    • Demonstrated problem-solving and critical thinking skills
    • Demonstrated organizational skills
    • Demonstrated ability to train and coach others

Senior Project Engineer

We are seeking a highly motivated individual to join us as a Sr. Project Engineer to support the Director of Engineering and Capital Projects and his team full time. Overseeing, coordinating, and auditing new plant constructions or modification of the existing commercial, clinical and research facilities. This position will be the central point of contact, coordination, and organization of the technical documents associated with the project; will assist with technical problem solving as well as project planning, developing the project plan and scope, and incorporating these into the bid package for the installation contract; will provide daily documentation of project activities; and will participate in the coordination of the installation plan and daily contractor activities with the Plant representatives as assigned..
Responsibilities may vary in the different phases of the project and may include:
• Develop GMP Facilities mechanical, utilities, plumbing, Electrical and Automation (BMS & EMS) standards.
• Develop and maintain documentation and standards (SOP) for facilities and engineering operations.
• Develop and maintain a part 11 compliant library of submitted project documents and produce a standard to maintain TOPs and historic document management.
• Develop facilities and Equipment User Requirement Specifications (URS)
• Coordinating and processing responses to Requests For Information (RFI’s) from the installation contractor by working with the appropriate Owner’s Engineers.
• Maintain current drawing sets and specifications with archive history.
• Audit contractor and subcontractor installation activities and materials for conformance to the drawings and specifications.
• Manage and coordinate GMP equipment delivery, installation and validation.
• Audit contractor Safety in the work operations along with other Team members.
• Active participation in the weekly progress meetings with the contractor regarding technical items. Write and distribute weekly progress meeting minutes as assigned.
• Monitor the overall project milestone schedule and the contractor’s installation schedule and report issues and concerns to the Team.
• Audit contractor as-built drawings in-progress and perform field observations as assigned.
• Coordinate new plant commissioning, validation and start up activities

EDUCATION AND EXPERIENCE/ SKILL REQUIREMENTS
• Bachelor Degree in Mechanical Engineering, Electrical Engineering, Engineering Management, Engineering Technology, Construction Management or equivalent experience.
• Familiarity with manufacturing facility mechanical systems and ability to work with and modify EMS and BMS systems.
• Experience in GMP, FDA regulated field (Bioscience experience a plus).
• Detail oriented with excellent written and verbal communication skills.
• Willingness to learn and grow
• Must be proficient in MS Office (Word, Excel, and PowerPoint).

Reliability Engineering Manager

GENERAL DESCRIPTION:

We are seeking a Reliability Engineering Managerto oversee the Reliability Centered Maintenance (RCM) operations of a laboratory and tissue processing facility in Thousand Oaks, California.  In addition to the Thousand Oaks facility’s oversight activities, this position will also assist in the design, construction and operation of the company’s future facility for clinical and commercial manufacturing in Tarzana, California.  

RESPONSIBILITIES:

As the Reliability Engineering Manager duties will include: Working with the Sr. Director for Corporate Facilities to develop standard operating procedures (SOPs), standards and processes around calibrations, preventive maintenance, computerized maintenance management system (CMMS), equipment management system (EMS), maintenance repair & overhaul (MRO) and reliability engineering.  This includes:

  • Hiring the workforce needed to support department.
  • Development of preventive maintenance procedures.
  • Development of calibration procedures.
  • Develop and maintain MRO inventory.
  • Schedule corrective and preventive work orders.
  • Schedule calibrations.
  • Act as the System Administrator for the CMMS; Amici Asset Management Module
  • Act as the System Administrator for EMS; Fisher Scientific Smart Vue
  • Evaluate CMMS data to improve reliability of critical equipment.
  • Develop metrics around PMs, Calibrations, OOTs, Equipment Failures, MRO.
  • In collaboration with Facilities Manager, coordinate outside vendor activities.
  • Act as department SOP owner.
  • Act as department CAPA owner.
  • Provide clerical support to Facilities and Engineering teams
  • Identify and implement corporate CMMS system.

EXPERIENCE & EDUCATION:

  • Bachelors of Science degree preferred
  • A minimum of five years of experience working in an FDA regulated environment
  • A working knowledge of Computerized Maintenance Management Systems; Blue Mountain a plus
  • Self-starter with the ability to work with minimum supervision
  • Proven leadership and development of staff.
  • Excellent verbal and written communication skills
  • The ability to multitask and exercise good judgment
  • The ability to work in a fast pace environment and maintain a high level of customer service
  • Detailed oriented with good follow-up skills
  • Proficient in computer usage with standard business software

Director / Senior Director, R&D Quality and Compliance

Instil Bio is seeking a Director / Senior Director of R&D Quality and Compliance who will serve as a strategic and tactical quality professional in managing compliance related to Good Clinical Practices (GCP’s), Good Laboratory Practices (GLP’s), Good Pharmacovigilance Practices (GPVP’s) and other related activities. Responsible for ensuring oversight of compliance with GCP, GLP, and GPVP global regulations, industry best practices, and internal policies and procedures. Partner with the Clinical Development, Clinical Operations, and Pharmacovigilance organizations to provide strategic GCP, GLP, and GPVP compliance oversight for clinical studies and internal operations.    

Responsibilities

These may include but are not limited to:

  • Attend project meetings, representing Quality and Compliance and provide GCP/GPVP/GLP insight and oversight
  • Perform review and gap analysis of existing quality systems and lead development and implementation of additional or alternative solutions
  • Design and implement a risk- based audit program
  • Plan, manage, and perform GCP/PVP/GLP audits: Investigational sites, various vendors supporting conduct of clinical studies, GCP/GVP/GLP system audits, clinical studies report, etc.
  • Evaluate audit observations and trends and develop periodic compliance reports for management
  • Monitor and drive quality issues to resolution. (e.g., Closure of Audit Reports, develop and track post auditing corrective actions plans, as applicable)
  • Responsible for managing GCP/GPVP/GLP compliance activities / non-conformances associated with drug development programs
  • Understand and interpret current pharmaceutical regulations and ICH guideline requirements pertaining to GCP/GPVP/GLP and advise the Clinical development teams on all relevant issues
  • Review Clinical Development SOPs to ensure compliance with all applicable regulatory authorities
  • Work in conjunction with other Quality areas to ensure proper representation throughout the organization, as needed
  • Conduct internal system audits to ensure compliance with applicable regulations, SOPs and policies and advice on process improvements in the functional areas
  • Ensure annual audit plans are developed and audit activities are completed according to plan
  • Communicating audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs), addressing root causes
  • Lead management of regulatory agency inspections and coordination of responses to any regulatory agency finding
  • May lead change projects which have strategic impact on the organization
  • Analyze trends in industry/regulatory environment that would necessitate future changes
  • Facilitate and support inspection readiness activities
  • Develop and provide independent periodic reports to management on overall compliance status
  • Ensure that the company, its contractors, and vendors are prepared for FDA and Health Authority inspections 

Requirements, Knowledge, Skills and Abilities

  • Minimum of bachelor’s degree in a scientific discipline with at least 12 years of work experience in the Pharmaceutical/Biotechnology industry with at least 5 years in Quality (an equivalent combination of education and experience may be considered)
  • Expert knowledge of FDA and ICH GxP regulations and guidelines with focus on GCP, GLP, and GPVP
  • Experience in leading high performing Quality teams
  • Experience in hosting and managing GCP FDA and Health Authority inspections
  • Excellent people leader with strong coaching and mentoring skills
  • Experience identifying and evaluating risks and executing efficient and effective mitigations
  • Practical knowledge and experience identifying key performance metrics for quality indicators, setting targets to maintain a state of control while identifying areas for improvement.
  • Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams in a fast growth environment
  • Demonstrated problem-solving and critical thinking skills
  • Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment
  • Travel may be required up to 20% of the time

Facilities & Maintenance Manager

GENERAL DESCRIPTION:

We are seeking a Facilities and Maintenance Manager to oversee the facilities and maintenance operations of a laboratory and tissue processing facility in Thousand Oaks, California.  In addition to the Thousand Oaks facility’s oversight activities, this position will also assist in the design, construction and operation of the company’s future facility for clinical and commercial manufacturing in Tarzana, California.

RESPONSIBILITIES:

The Facilities and Maintenance Manager will oversee all building-related activities.  You will be responsible for preserving the good condition of infrastructure and ensure the facilities are safe and well-functioning.

  • Plan and coordinate all installations (telecommunications, heat, electricity etc.) and refurbishments
  • Manage the upkeep of equipment and supplies to meet health and safety standards
  • Inspect buildings’ structures to determine the need for repairs or renovations
  • Draft and work within department budget
  • Perform analysis and forecasting
  • Keep financial and non-financial records
  • Handle insurance plans and service contracts
  • Process and approve facilities purchasing activities
  • Review utilities consumption and strive to minimize costs
  • Select and manage facilities support vendors and contractors
  • Supervise all staff facilities staff (custodians, technicians, groundskeepers etc.) and external contractors
  • Control activities like parking space allocation, waste disposal, building security etc.
  • Allocate office space according to needs
  • Working with EH&S to ensure a safe work environment and ongoing programs
  • Manage the preventive maintenance program
  • Establish an equipment/system reliability program utilizing data acquired from CMMS including spare parts availability
  • Ensure that department personnel training is current
  • Support all Quality Assurance programs including Change Control and Observation Reports
  • Support drafting and maintaining department SOP’s
  • Manage Pest Control Program
  • Execute projects as assigned

EXPERIENCE AND EDUCATION:

  • Degree in Engineering is a plus, but not required
  • 10+ years’ experience working in an FDA regulated environment
  • A working knowledge of Computerized Maintenance Management Systems
  • A working knowledge of facilities equipment and preventive maintenance programs
  • 3+ years’ experience in managing people, programs and/or budgets
  • Excellent verbal and written communication skills
  • The ability to multitask and exercise good judgment
  • The ability to work in a fast pace environment and maintain a high level of customer service
  • Detailed oriented with good follow-up skills
  • Proficient in computer usage with standard business software
  • Planning and purchasing experience in a manufacturing environment

Senior Facilities Technician

We are seeking a 1st shift Sr. Facilities and Maintenance Technician to oversee a laboratory and tissue processing facility in Thousand Oaks, California.  In addition to the Thousand Oaks facility’s oversight activities, this position will also assist in the operation and maintenance of the company’s future facility for clinical and commercial manufacturing in Tarzana, California.

Responsibilities include but are not limited to:

GENERAL DESCRIPTION:

Working with minimal supervision you will perform scheduled Preventive Maintenance and Corrective Maintenance on complex equipment and systems in the manufacturing, laboratory and office areas.   You will evaluate equipment performance and recommend improvements.   Coordinate maintenance activities with area supervisors.   Order spare parts, replacement parts, solicit vendor quotes and oversee vendor/contractor work within your area of responsibility.   Provide guidance to, and train, junior associates; and perform special projects as assigned. 

RESPONSIBILITIES:

Responsibilities include but are not limited to:

Working with minimal supervision you will perform scheduled Preventive Maintenance and Corrective Maintenance on complex equipment and systems in the manufacturing, laboratory and office areas.   You will evaluate equipment performance and recommend improvements.   Coordinate maintenance activities with area supervisors.   Order spare parts, replacement parts, solicit vendor quotes and oversee vendor/contractor work within your area of responsibility.   Provide guidance to, and train, junior associates; and perform special projects as assigned. 

  • Maintain a safe work environment; work in a safe manner following all safety SOP’s and wear Personal Protective Equipment as required
  • Maintain critical equipment that support the manufacturing and R&D groups
  • Plan and schedule, Corrective, Preventive, and Calibration work orders, with customers
  • Maintain accurate records keeping equipment and systems cGMP compliant at all times
  • Work independently and make sound judgments regarding work methods and tools
  • Proactively support the Corporations, Companies, Departments and Personal goals and objectives
  • Maintain your Technical Training Profile current with no delinquent notices
  • Receive gasses and check status daily
  • Able to work second shift, weekend shift support, on call hours and shutdowns required
  • Receive and deliver vendor delivered supplies to appropriate locations
  • Ability to check and respond to Equipment Monitoring System Building Management Systems
  • Other duties as assigned

REQUIREMENTS:

  • High School diploma, relevant trade certification, and some college or vocational training in engineering or facilities
  • Must have a strong work ethic and demonstrate dependability and timeliness.
  • At least 3-5 years of maintenance experience in a biotech or pharmaceutical company
  • GMP experience required
  • Exposure to operations involving engineering disciplines including Electrical, Mechanical, Civil, Structural, Environmental, and Industrial
  • Demonstrated understanding of systems needed to manage a GMP facility such as: HVAC, electrical, process systems, plumbing/piping, general maintenance, pest management, both interior and exterior
  • Must be able to lift, carry, push and/or pull 50 lb. of equipment or supplies
  • Must be able to squat, bend, kneel, climb, and or reach for 75% of a shift
  • Must be able to stand, walk, and/or move about for 75% of a shift
  • Good interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

Associate Scientist/Senior Research Associate, Analytical Sciences

Instil Bio is looking for an Associate Scientist/Sr. Research Associate, Analytical Sciences in the Greater Los Angeles area.

The successful candidate will execute, troubleshoot and support optimization multi-parameter flow cytometry assays. The individual will support the establishment of Analytical Sciences laboratory and execute assays to support method development and testing, transfer and regulatory filing activities. The individual will support successful lifecycle activities related to process and methods. The candidate will present data to colleagues and leadership and support manufacturing and analytical startup.

Skills/Knowledge:  B.S/M.S in immunology related fields or relevant life science degrees.  2+ years of experience in a relevant field. Familiarity with GMP, GLP and ICH guidelines. Ability to adapt and function in a dynamic and cross-functional environment.  Self-motivated, technically driven, and willing to take on duties outside of general role.  Excellent verbal, written, and presentation skills.  Ability to interpret and communicate relevant developments in academic literature. 

Senior Scientist/Scientist, Analytical Sciences

Instil Bio is looking for a Senior Scientist/Scientist, Analytical Sciences in the Greater Los Angeles area.

The successful candidate will be responsible for providing scientific and technical expertise and perform laboratory based studies to develop, troubleshoot, qualify and transfer assays across multiple platform technologies including flow cytometry, ddPCR, cell culture and ELISA. The individual will support the establishment of Analytical Sciences laboratory to support testing, new technology evaluation and regulatory filing activities. The individual will support successful lifecycle activities related to process and methods. The candidate will author technical documents, present data to colleagues and leadership and support manufacturing and analytical startup. Occasional international travel is required to support global sites.

Skills/Knowledge: MS or Ph.D in immunology related fields or relevant life science degrees.  4+ years of experience in a relevant field. Familiarity with GMP, GLP, ICH guidelines and biopharmaceutical regulations for various regulatory bodies, such as the FDA and EMA.  Background in cell therapy is preferred. Ability to adapt and function in a dynamic and cross-functional environment.  Self-motivated, technically driven, and willing to take on duties outside of general role.  Excellent verbal, written, and presentation skills.  Ability to interpret and communicate relevant developments in academic literature.  Creative thinking skills to challenge current understanding and help define process improvement and optimization opportunities. 

Senior Scientist/Scientist, Analytical Sciences

Instil Bio is looking for a Senior Scientist/Scientist, Analytical Sciences in the Greater Los Angeles area.

The Senior Scientist/Scientist will be responsible for providing scientific and technical expertise and perform laboratory based studies to design, develop, troubleshoot, qualify and transfer assays across multiple technologies including multi-parameter flow cytometry, biological potency assays and cell culture based assays. Additionally, the successful candidate will be responsible for routine execution of assays to support regulatory filings, evaluating new technologies, analysis of complex data for trend analysis in a cross functional collaborative setting and authoring technical reports. The candidate will present data to colleagues and leadership and, support manufacturing and Analytical Sciences start-up. As the company develops, the candidate will be expected to train and manage new analysts, lead efforts to support company milestones. Occasional international travel is required to support global sites.

Skills/Knowledge:  Ph.D or equivalent, in immunology related fields or relevant life science degrees.  At least 5+ years of experience in a relevant field. Familiarity with GMP, GLP, ICH guidelines and biopharmaceutical regulations for various regulatory bodies, such as the FDA and EMA.  Background in tumor immunology is preferred. Ability to adapt and function in a dynamic and cross-functional environment.  Self-motivated, technically driven, and willing to take on duties outside of general role.  Excellent verbal, written, and presentation skills.  Ability to interpret and communicate relevant developments in academic literature.  Creative thinking skills to challenge current understanding and help define process improvement and optimization opportunities. 

Director, Quality Assurance and Systems

Instil Bio is looking for a Director, Quality Assurance and System in the Greater Los Angeles and Thousand Oaks area.

This position is responsible for leading the Quality Assurance operation and establish a global quality system to support compliance activities of clinical development and commercialization of Instil bio’s Tumor Infiltrating Lymphocyte Products.

  • Develop and maintain phase-appropriate quality systems for both clinical and commercial manufacturing environments, including document management, deviations, CAPA, change control, training and auditing.
  • Provide QA oversights and leadership to ensure timely disposition and delivery of GMP compliant manufacturing drug products that are fit for purpose.
  • Provide quality oversight and GMP guidance to manufacturing, QC, engineering/facilities. Furthermore, you will be responsible for developing and maintaining processes and procedures to ensure appropriate quality oversight while demonstrating compliance with cGMP.
  • Act as subject matter expert for quality during audits and regulatory inspections.
  • Strong work knowledges of quality system and regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10) in both U.S. and E.U. are required.

Minimum Qualifications:

  • Bachelor’s degree in Chemistry, Biochemistry, Biology, Chemical Engineering or other Science or Technical discipline.

Senior Manager/Associate Director, QC Microbiology

Instil Bio is looking for a Senior Manager/Associate Director, QC Microbiology in the Greater Los Angeles and Thousand Oaks area.

The successful candidate will be responsible for the establishment of clinical and commercial QC microbiology and environmental testing laboratory to support release of Instil Bio’s TIL products and regulatory filing. In this role, you will provide strategic leadership and subject matter expertise in the EM/PM program, sterility control, utilities monitoring and in-process and final product laboratory testing. Additionally, the individual will lead the efforts in lab planning, scheduling, inventory management, lab safety and compliance and oversee continuous improvement efforts to ensure operational efficiency and compliance states. GMP microbiology laboratory management experiences with strong knowledge in cell therapy manufacturing and rapid microbiological methods are required.

Senior Manager/Associate Director, QC Analytical

Instil Bio is looking for a Senior Manager/Associate Director, QC Analytical in the Greater Los Angeles and Thousand Oaks area.

The successful candidate will be responsible for the establishment of clinical and commercial QC GMP laboratory to support method transfer, qualification/validation, lot release, laboratory investigation, and regulatory filing activities. The individual will lead the efforts in lab planning, scheduling, inventory management, lab safety and compliance and oversee continuous improvement efforts to ensure operational efficiency and compliance states. QC GMP laboratory management experience with solid technical knowledge in flow cytometry, cell culture, ELISA and ddPCR are required.

Senior/Principal Engineer

Instil Bio is seeking a driven and experienced Senior/Principal Engineer in the Greater Los Angeles and Thousand Oaks area.

Senior/Principal Engineer in our Process Sciences and Engineering group.  This person will

lead execution of process development studies and procedures that involve knowledge of basic engineering principles.  Manage a small team of engineers and scientists to drive projects and facilitate career development.  Interpret department strategy into an actionable plan for team members.  Authoring of study protocols, reports, procedures, batch records.  Presentation of experimental results to colleagues and cross-functional leadership.  Provide technical leadership for troubleshooting in a laboratory setting.  Collaborate in a cross-functional setting to interpret study results and contribute to decisions for subsequent study design.  Support manufacturing and analytical development startup.  Support laboratory readiness and organization of initial site activities.  Provide technical and operational input to process development studies and during cross-functional meetings

Skills/Knowledge:  BS, MS, or Doctorate in bioengineering, chemical engineering, biotechnology, immunology, or relevant technical degrees.  5+ years of experience in a relevant field.  3+ years of experience managing a technical team.  Familiarity with biopharmaceutical regulations for various regulatory bodies, such as the FDA and EMA.  Experienced with design of experiments, study prioritization, and risk management.  Familiarity with general mammalian cell culturing and aseptic techniques.  Familiarity with GLP and GMP regulations.  Highly experienced with statistical methods for engineering and basic sciences.  Ability to adapt and function in a dynamic and cross-functional environment.  Self-motivated, technically driven, and willing to take on duties outside of general role.  Contribute to maintenance of a safe and collaborative work environment in accordance with policies/procedures/regulations.  Excellent verbal, written, and presentation skills.  Ability to interpret and communicate relevant developments in academic literature.  Creative thinking skills to challenge current understanding and help define process improvement and optimization opportunities.  Leverage these process improvements and optimizations to contribute to the IP portfolio

Associate Process Engineer/Process Engineer

Instil Bio is seeking a driven and experienced Associate Process Engineer/Process Engineer in the Greater Los Angeles and Thousand Oaks area.

Associate Process Engineer/Process Engineer in our Process Sciences & Engineering group. This person will be responsible for execution of process development studies and procedures that involve knowledge of basic engineering principles. Authoring of study protocols, reports, procedures, batch records. Presentation of experimental results to colleagues and department leadership. Provide technical support for troubleshooting in a laboratory setting. Collaborate in a cross-functional setting to interpret study results and contribute to decisions for subsequent study design. Support manufacturing and analytical development startup. Support laboratory readiness and organization of initial site activities.

Skills/Knowledge:  BS or MS in bioengineering, chemical engineering, biotechnology, immunology, or relevant technical degrees.  Familiarity with general mammalian cell culturing and aseptic techniques.  Familiarity with GLP and GMP regulations.  Experience with statistical methods for engineering and basic sciences.  Ability to adapt and function in a dynamic and cross-functional environment.  Self-motivated, technically driven, and willing to take on duties outside of general role.  Contribute to maintenance of a safe and collaborative work environment in accordance with policies/procedures/regulations.  Excellent verbal, written, and presentation skills.  Ability to interpret and communicate relevant developments in academic literature.  Creative thinking skills to challenge current understanding and help define process improvement and optimization opportunities.

Senior Scientist, Computational Immunology

Instil Bio is looking for a Senior Scientist, Computational Immunology in the Greater Los Angeles to Thousand Oaks area.

We are seeking a Senior Scientist of computational immunology to lead Instil Bio’s discovery efforts to play a pivotal role in advancing the key TIL engineering programs. The successful candidate will manage a small team of scientists and research associates to develop new internal technology assets with the ultimate goal of developing cell therapy IND candidates for the treatment of solid tumors. In this role, the candidate will be directly reporting to Vice President, Head of Research.

VP of Quality

Instil Bio is looking for a VP of Quality in the Greater Los Angeles to Thousand Oaks area.

This individual will be responsible for supporting a growing organization that manufactures a tumor-infiltrating lymphocyte (TIL) treatment. This role will work to establish an international quality organization while providing advice and ensure that manufactured products meet current industry best practices (GMP, GDP, GTP).