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.
TR Associate / Clinical Operations
Instil Bio is seeking a driven and experienced TIL Recovery Associate. 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 Good Clinical Practice (GCP) and current Good Tissue Practice (cGTP) requirements. This role will comprise multiple critical functions:
- Delivery of supplies to Clinical Sites
- TIL Recovery Process
- Tumor Preparation (Includes trimming, weighing, packaging tumor tissue & training of clinical site staff to perform Tumor Preparation steps)
- Tumor Digestion (Addition of Media and Equipment process initiation)
- Tumor Cryopreservation (Addition of Cryoprotectant and Freezing of Tumor Tissue)
- Biomedical packaging, labeling, shipping LN2 shippers
- Data input into the Instil Bio Clinical Logistics Portal
- Maintain cGTP of Tumor Procurement Hub per 21 CFR 1271 in regard to:
- Environmental Controls and Monitoring
- Supplies and Reagents
- Labeling Controls
- Records Maintenance and Appropriate Tracking
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 TIL Recovery Associate 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 maintenance of the assigned regional hub to meet all GCP/GTP requirements
This position will routinely interact with Clinical Logistics, Clinical Study Teams, Clinical Research Organizations, 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 cGTP requirements
- Shipping TIL starting material to the manufacturing facilities
- 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 Clinical Logistics on updates/statuses of TIL recovery process.
- Communicates TIL recovery, packaging, and labeling requirements to clinical site staff.
- Operationally supports Clinical Logistics during Dry Run preparation.
- Participates in and provides TIL recovery updates at meetings as assigned.
- Proactively identifies potential TIL recovery process issues/risks.
- 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 be required to prepare media, sterilize instruments, and use laminar flow hood for processing.
Requirements and Recommendations:
- Associate’s degree in surgical tech with 2 years of work experience as a surgical technician, in the field of tissue/organ recovery, in the field of tissue processing, or any other related scientific/technical field
- BS or BA in a relevant scientific discipline with 1 year of work experience as a surgical technician, in the field of tissue/organ recovery, in the field of tissue processing, or any other related scientific/technical field
- 3 years of work experience as a surgical technician, in the field of tissue/organ recovery, in the field of tissue processing, or any other related scientific/technical field
- It is critical that you have:
- Basic understanding of Anatomy
- Previous Tissue/Organ Recovery, Surgical Technician, Tissue Processing experience
- Valid driver’s license, registration, and insurance
- Own means of transportation
- Excellent time management skills
- Excellent interpersonal ability
- It is strongly encouraged that this role has:
- Certified Eye Bank Technician (CEBT)
- Certified Tissue Banking Specialist (CTBS)
- Certified Surgical Technician
- Knowledge of FDA regulations as applied to Human Cells, Tissues, and Cellular and Tissue-Based Products
- Knowledge of HTA regulations
- Personal Skills:
- Microsoft Office Suite
- Strong Communication & Presentation Skills