Manager, Quality Control Laboratory Potency Assays
Iovance Biotherapeutics
- Philadelphia, PA
- Permanent
- Full-time
- All duties are performed independently with minimal supervision and oversight.
- Act as technical subject matter expert (SME) for potency testing and related activities.
- Responsible for the scheduling and timely execution of potency testing and related activities and the respective data review and release.
- Manage the day-to-day GMP QC Potency testing activities at the iCTC facility including quality control testing and support testing for cell therapy intermediates, final product, and stability testing.
- To ensure target turn-around times are met, may be required to assist in execution of assays.
- Ensure that QC staff are appropriately trained and are performing tests in accordance with method procedures and are consistent with implementing the required techniques.
- Responsible for data analysis and final result reporting to support product lot release with adherence to turnaround times.
- Ensure that the daily GMP quality control laboratory testing activities at the iCTC facility are executed with minimal to no errors and ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
- Lead/Support thorough GMP investigations for out of specification test results, corrective actions, and verification of effectiveness, and other quality events.
- Provide technical problem solving for issues pertaining to GMP quality control.
- Support product stability programs including timely scheduling of stability testing, stability data analysis, and final reporting of stability data.
- Responsible for the generation/revision and/or review of documentation, such as SOPs, protocols and reports, especially for potency assays.
- Responsible for ensuring timely review of laboratory data and logbooks in the potency laboratory space.
- Support LIMS initiative.
- Ensure trending of analytical performance is performed, as required.
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
- Support Health Authority inspections.
- Organize and conduct Tier 1 and other QC-related meetings.
- Successfully interface and provide input with multi-disciplined teams.
- Ability to effectively manage multiple priorities involving dynamic and aggressive timelines at a high level of productivity.
- Other responsibilities, as assigned.
- Minimum of a Bachelor’s degree in Biology, Biochemistry, or related scientific field.
- Six (6) to eight (8) years of experience in the pharmaceutical industry within a Quality Control role with increasing project and management responsibilities; experience with cell therapy products is a plus.
- Solid understanding and functional knowledge with hands-on experience with the following: Cell Based Potency Assays and supporting ELISA platforms and cell maintenance (primary cells and continuous cell lines) and cell count determination (NC 200)
- In-depth knowledge of ICH/USP/EMA guidelines in a GMP QC setting.
- Experience in managing and leading a team of scientific personnel.
- Highly proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
- Experience in authoring quality documents (e.g., deviations, change controls, CAPAs, investigations, etc.)
- Experience with laboratory information management systems, i.e., LabVantage LIMS.
- Successfully interface with multi-disciplined teams.
- Extremely detail-oriented with strong technical skills.
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- High level of ownership and accountability.
- Demonstrate sense of urgency; ability to recognize time sensitivity.
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
- Advanced degree (MSc., Ph.D.) in Biology, Biochemistry, or related scientific field is preferred.
- Experience with cell therapy products is a plus.
- Experience with multi-color flow cytometry assays is a plus.
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
- Must meet requirements for and be able to wear a half-face respirator.
- Able to stand and/or walk 90% (and sit 10%) of the scheduled workday 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 motions.
- Must be able to lift and carry objects weighing 30 pounds.