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Supervisor, Quality Control, Microbiology
2 months ago
About Iovance Biotherapeutics Inc.
We are a leading biotechnology company dedicated to developing innovative cancer therapies. Our mission is to improve the lives of patients with cancer by delivering cutting-edge treatments that address the unique needs of each individual.
Job DescriptionThe Supervisor, Microbiology Testing & Environmental Monitoring plays a critical role in supporting the environmental monitoring and microbiology testing programs at our Cell Therapy Center (iCTC). This is a working Supervisor role that oversees the routine operations and performs testing such as sterility testing, endotoxin testing, media growth promotion, environmental monitoring, plate reading, data review, microbiology investigations, and other microbiology methods as needed to support product release.
Key Responsibilities:- Oversee day-to-day operations in the QC Microbiology laboratory in support of environmental monitoring and batch-related microbiology testing on the weekend shift.
- Perform daily cGMP quality control laboratory microbiological testing activities and environmental monitoring of the cleanroom areas at the iCTC facility as required.
- Schedule and perform routine gas sampling at the iCTC facility as required.
- Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
- Oversee growth promotion testing of microbiological media using both ATCC and in-house isolates.
- Oversee environmental monitoring of the manufacturing areas, including batch-related EM, is performed accurately and according to the manufacturing schedule.
- Ensure all in-process and lot release microbiology testing is performed and reviewed accurately and timely.
- Ensure timely review of routine environmental monitoring data, microbiology testing data, and excursions and OOS reports are completed accurately and timely.
- Work closely with contract labs to ensure that samples are submitted and tested in a timely manner.
- Ensure gowning qualifications and re-qualifications for personnel needing access to classified manufacturing areas is performed, tracked, and trended.
- Draft and execute protocols in support of site contamination control programs, as needed.
- Oversee the maintenance and build of a microbial identification database for all in-house isolates recovered from the various monitoring programs.
- Work closely with Sterility assurance team to ensure trend analysis and trend reports for environmental monitoring data are performed timely.
- Support site qualification/validation/commissioning activities as needed.
- Serve as a qualified trainer, provides guidance to other analysts.
- Initiate and investigate deviations.
- Mentor and support career development of direct reports.
- Support audits and inspections as needed.
- Bachelor's degree in Biology, Microbiology or related scientific field is required.
- Minimum five (5) years of experience in a cGMP Quality Control microbiology role.
- Prior experience in managing a team and having direct reports.
- Basic knowledge of Compendial (e.g., USP, EP, JP, ) requirements and standards.
- High proficiency in aseptic techniques when executing microbial test methods and environmental monitoring.
- Proficient in performing technical writing (e.g., test methods, SOP's, protocols, ).
- Strong technical writer with experience in writing protocols, deviations, investigations, SOPs.
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- High level of ownership and accountability.
- Experience with cell therapy products is a plus.
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE).
- Must meet requirements for and be able to wear a half-face respirator.
- Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
- Must be able to use near vision to view samples at close range.
- Able to crouch, bend, twist, reach, and perform activities with repetitive motion.
- Must be able to lift and carry objects weighing 45 pounds.
- Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities.
- This position will work in both an office and a manufacturing lab setting.
- When in the lab, must be able to work in a Lab setting with various chemical/biochemical exposures, including latex and bleach.
- Able to work in cleanroom with biohazards, human blood components, and chemicals.
- Potential exposure to noise and equipment hazards and strong odor.
