QC Cell Therapy Supervisor - Permanent - Philadelphia, PA

Proclinical is seeking a dedicated and skilled QC Cell Therapy Supervisor. This is a permanent position located in Philadelphia, PA.

Primary Responsibilities:

The ideal candidate will have practical experience in at least two of the following areas: cell maintenance and counting (using NC-200), cell-based potency testing with various immunoassays (such as ELISA), and/or assays for identification, characterization, and potency using multi-color flow cytometry platforms. This role is integral to supporting the establishment of QC analytical release assays and other related tasks in a newly constructed facility dedicated to cell therapy products.

Skills & Requirements:

Bachelor's degree in a relevant field (biological sciences or equivalent) or an equivalent combination of education and experience.6+ years' experience in the biopharmaceutical industry in a QC role; experience with cell therapy products is advantageous.Proficiency in technical writing, including test methods, SOPs, and protocols.Hands-on experience with at least one of the following: Cell-Based Potency Assays, supporting ELISA platforms, or multi-color flow cytometry for identification, characterization, and potency analysis.Strong understanding of biological drug development in relation to QC.Exceptional attention to detail and technical skills.Strong written and verbal communication abilities.Proven ability to manage multiple priorities and meet aggressive timelines efficiently.Demonstrated sense of urgency and ability to recognize time-sensitive tasks.Flexible and adaptable with a readiness to take on new challenges.

The QC Cell Therapy Supervisor will:

Conduct daily GMP QC laboratory testing activities at the facility.Oversee laboratory activities, including release testing and maintenance.Manage the technical transfer, qualification, and validation of QC Analytical test methods for in-process materials, lot release, and stability as needed.Author, review, and approve SOPs, protocols, reports, specifications, and other QC documents.Lead investigations into out-of-specification test results, implement corrective actions, and verify their effectiveness.Ensure daily GMP QC laboratory testing activities are executed accurately and in compliance with all applicable procedures, standards, and GMP regulations.Expand technical skills through qualification on all QC analytical release assays.Act as a qualified trainer on QC analytical release assays when needed.Foster positive working relationships with internal and cross-functional teams.Maintain a high level of efficiency and accuracy in a fast-paced environment.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at (+1) 267-428-7770 or m.raletz@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.

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