QA Sr. Specialist, Quality Operations


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.

QA Sr. Specialist, Quality Operations

Instil Bio is seeking a driven and experienced QA Sr. Specialist, Quality Operations.  The successful candidate will be a quality professional with extensive Quality Operations experience and be responsible for providing technical expertise, batch review/approval of processes, and documentation associated with raw materials inspection, in-process and final product manufacturing and disposition.

In this role, the QA Sr. Specialist, Quality Operations will be responsible for partnering with Operations during the Clinical and Commercial manufacturing process, conduct in-process and final product disposition, facilitate the Quality Operations processes, provide technical support on Quality Operations standards and processes to team members as an SME.

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 Operations.

Responsibilities (include but not limited to):

  • Support and execute cGMP activities in support of manufacturing, labeling, batch record review and lot disposition (including raw materials)
  • Execute cGMP QA Operations procedures in support of clinical and commercial manufacturing
  • Provide support for deviations, non-conforming events, laboratory out-of-specifications, and corrective action/preventative action investigations
  • Provide support for change controls 
  • 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
  • Serve as site SME and support for Quality Operations related activities and participates in audits and regulatory inspections
  • Prepare, maintain, and report operations data for KPI and site metrics
  • Interface with cross-functional teams to resolve Quality Operations related issues
  • 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 6 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 operations/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