Quality Control Supervisor: Cell Therapy

Quality Control Supervisor: Cell Therapy - Perm - Philadelphia, PA

Proclinical is seeking a dedicated and experienced Supervisor specializing in Cell Therapy for the Quality Control Analytics team at a biotech company. This role is integral to our operations, focusing on in-process, final drug product, and stability testing for clinical and commercial lots.

Primary Responsibilities:

The successful candidate will have hands-on experience in cell maintenance, cell count determination, cell-based potency using various immunoassays, and/or identification/characterization/potency assays using multi-color flow cytometry platforms. This position is crucial in supporting the ramp-up of QC Analytical release assays in our newly built facility for cell therapy products.

Skills & Requirements:

• Bachelor's degree in a relevant discipline (biological sciences or equivalent) or an equivalent combination of education and experience.
• Minimum six years of experience in the biopharmaceutical industry within a QC role, experience with cell therapy products.
• Solid understanding and functional knowledge with hands-on experience with Cell Based Potency Assays and supporting ELISA platforms and/or Multi-color flow cytometry.
• 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.

The Quality Control Supervisor: Cell Therapy's responsibilities will be:

• Supervise all laboratory activities, including release testing and laboratory maintenance.
• Oversee the technical transfer, qualification, and validation of QC Analytical test methods.
• Perform daily GMP QC laboratory testing activities.
• Author, review, and approve SOPs, protocols, reports, specifications, and other QC documents.
• 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.
• Serve as a qualified trainer and technical reviewer on all QC analytical release 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.

Compensation:

• USD 125 000.00 - 130 000.00 per annum

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDSCIC