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Supervisor, Quality Control Analytics
2 months ago
This role will apply appropriate cGMPs and regulatory requirements in the product development life cycle, including, but not limited to, lot release and stability testing, method qualification and validation, method technology transfers, and writing/review of QC procedures. The Supervisor, Quality Control Analytics role will have direct oversight of the QC analysts and performance.
Essential Functions and Responsibilities
All duties are performed independently with minimal supervision and oversight.
Supervise the execution of all laboratory activities, including release testing and laboratory maintenance activities.
Supervise the technical transfer, qualification, and validation of QC Analytical test methods for in-process materials, lot release, and/or stability, as needed.
Perform daily GMP QC laboratory testing activities
Author, review, and approve SOPs, protocols, reports, specifications, and other QC documents.
Ensure trending data input for all generated data is performed timely.
Lead investigations for out-of-specification test results, corrective actions, and verification of effectiveness.
Support product stability programs including generation of stability protocols, execution of stability testing, and transfer of stability results to external QC.
Ensure that the daily GMP QC laboratory testing activities at the facility are executed with minimal to no errors and ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
Increase breadth of technical abilities through qualification on all QC analytical release assays.
Serve as a qualified trainer on all QC analytical release assays, as needed.
Serve as a qualified technical reviewer on all QC analytical assays, as needed.
Support professional development of QC Analytics team members.
Establish positive working relationships with internal and cross-functional teams.
Support problem solving for technical issues pertaining to GMP QC, working alongside technical SMEs, as needed.
Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment.
Support Health Authority inspections.
Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
Bachelor’s degree in a relevant discipline (biological sciences or equivalent) or an equivalent combination of education and experience.
Minimum six (6) years of experience in the biopharmaceutical industry within a QC role, experience with cell therapy products is a plus.
Solid understanding and functional knowledge with hands-on experience with at least one of the following: Cell Based Potency Assays and supporting ELISA platforms and/or Multi-color flow cytometry for identification, characterization, and potency analysis.
Broad knowledge of biological drug development with respect to QC.
Proficient in technical writing (e.g., test methods, SOP’s, protocols, etc.)
Extremely detail-oriented with strong technical skills
Strong written and verbal communication skills
Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
Demonstrate sense of urgency; ability to recognize time sensitivity.
Flexible and adaptable style with an eagerness to take on challenges.
Problem solver who not only identifies issues but leads efforts to resolve them
Experience supervising a team
Preferred Education, Skills, and Knowledge
Advanced degree in a relevant discipline (biological sciences or equivalent)
Experience with cell and/or gene therapy products
