Associate Director/Senior Manager QC Microbiology

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 patients 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.

Associate Director/Senior Manager QC Microbiology

InstilBio is seeking a driven and experienced Associate Director/Senior Manager in the Quality Control organization to provide strategic and operational direction for the QC microbiology group. The successful candidate will be responsible for the establishment of the QC microbiology and environmental testing laboratory to support release of Instil Bios TIL in-process and final products and regulatory filings (e.g. IND/BLA). In this role, you will have an overall responsibility for the planning, coordination, supervision and implementation of activities in the QC laboratory and aseptic manufacturing suite. The individual will report to Director, Quality Control and will mainly work in the QC testing laboratory in Tarzana, CA and occasionally in Thousand Oaks, CA.

Responsibilities (include but not limited to):

• Oversees execution of testing including routine microbial analysis, EM, reagent release testing and /growth promotion testing.
• Complete routine record review of test data and related documents for in-process testing, utility monitoring and in-process sample/drug product release.
• Accountable for the establishment and management of the Environmental Monitoring and Personal Monitoring programs.
• Oversees the QC Microbiology testing (stability, raw materials, in-process samples, final product), Aseptic Techniques Training programs, utilities testing program (microbiology), facilities qualification (EMPQ), clean room behavior, cleaning validations, and routine cleaning programs.
• Participates in investigations regarding out of specifications (OOS) results and EM excursions. Addresses deviations related to microbiology/EM procedures. Implements associated corrective actions.
• Maintain Microbiology Laboratory in a state of control, compliance, and inspection readiness. Interface with all auditors (internal and external) to ensure positive audit outcomes.
• Develop, revise and review SOPs, qualification/validation protocols and reports.
• Lead and develop a team of QC analysts.
• Effectively communicates with other departments and/or internal groups.
• Occasional domestic and international travel e.g. United Kingdom
• May conduct other Quality Control related duties, as assigned.

Basic Requirements

• Masters Degree and 8+ years experience in a GMP QC Microbiology laboratory, preferably in an aseptic manufacturing facility OR
• Bachelors Degree and 10+ years experience in a GMP QC Microbiology laboratory, preferably in an aseptic manufacturing facility.
• Strong knowledge of Environmental Monitoring requirements and tests (viable and non-viable), Aseptic Process Validation (APV), 21 CFR 210/211, USP/EP Microbiological methods and microbial identification.
• 5 years supervisory experience.
• Experience in aseptic techniques, sterile gowning procedures and clean room operations.
• Strong Experience in applying GMP in QC lab in conformance to U.S., EU, and ROW standards

Preferred Requirements

• Experience with the simultaneous management of multiple products through early phase clinical trials.
• Experience qualifying GMP manufacturing facilities (EMPQ), utilities qualification and validation).
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Demonstrated ability to develop, coach, and mentor employees.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Familiarity with latest rapid microbial detection methods.