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Job type: Permanent

Discipline: Biological Sciences

Location: United States

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

̽��ϼ� 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

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

̽��ϼ� Staffing is an equal opportunity employer.

INDSCIC