Lead Quality Control Specialist
2 months ago
We are seeking a highly skilled Quality Control Specialist to join our team at Iovance Biotherapeutics Inc. as a key member of our Quality Control department. The successful candidate will be responsible for ensuring the quality and integrity of our cell therapy products.
Key Responsibilities- Technical Expertise: Provide technical guidance and support to laboratory personnel on potency and flow testing activities, including training and development of new laboratory staff.
- Quality Control Testing: Perform daily GMP Quality Control laboratory testing activities at our integrated Cell Therapy Center (iCTC) facility with minimal to no errors, ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
- Data Analysis and Reporting: Perform data analysis and final result reporting to support product lot release, adhering to turnaround times and ensuring accuracy and quality of results.
- GMP Compliance: Perform all activities with respect to GMP/GDP compliance, including support for generation and revisions of documentation, such as SOPs, protocols, and reports, deviations, laboratory investigations, CAPAs, and change controls.
- Investigations and Problem-Solving: Support thorough GMP investigations for out-of-specification test results and other quality events, including initiation of DRs and LIRs, and technical problem-solving for issues pertaining to GMP Quality Control.
- Product Stability Programs: Support product stability programs, including execution of stability testing and stability data analysis.
- Efficiency and Quality: Operate at a consistent and exemplary level of efficiency, producing high-quality and accurate results, and perform peer and/or technical review of laboratory data and logbooks.
- Analysis and Trending: Analyze assay-specific analytical performance trending and support Health Authority inspections.
- Team Collaboration: Provide input to functional laboratory and cross-functional team meetings and operate at a consistent and exemplary level of efficiency, producing high-quality and accurate results.
- Education: Bachelor's degree in a relevant discipline (biological sciences or equivalent).
- Experience: Minimum three (3) years of experience in the pharmaceutical industry within a GMP Quality Control role; experience with cell therapy products is a plus.
- Skills and Knowledge: Experience with Flow Cytometry and Cell-based ELISA platforms, 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, and demonstrate sense of urgency; ability to recognize time sensitivity.
- Experience with Cell Therapy Products: Experience with cell therapy products is a plus and/or relevant technical skills (NC 200, ELISA, and/or Flow).
This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemicals, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.
Iovance Biotherapeutics Inc. is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact us.
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