QC Cell Therapy Supervisor

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)
  3. United States
Philadelphia, USA
Posting date: 27 Jun 2024
QA.MR.61159

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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