Quality Control Laboratory Manager

2 weeks ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Position Overview

Salary: Competitive

Role Summary:

The Quality Control Laboratory Manager for Potency Assays is responsible for overseeing the quality control testing processes for cell-based potency assays at Iovance Biotherapeutics Inc. This role encompasses a range of testing operations, including in-process assessments, final product evaluations, and stability studies for both clinical and commercial batches. A strong background in cell maintenance, cell count determination, and various immunoassays, particularly in the context of cell therapy products, is essential.

Key Responsibilities:

  • Independently perform all duties with minimal oversight.
  • Serve as the technical subject matter expert (SME) for potency testing and related activities.
  • Oversee the scheduling and execution of potency testing, ensuring timely data review and release.
  • Manage daily GMP quality control activities at the facility, including testing for cell therapy intermediates and final products.
  • Assist in assay execution as needed to meet turnaround times.
  • Ensure that QC personnel are adequately trained and adhere to method procedures.
  • Conduct data analysis and report final results to support product lot release.
  • Guarantee compliance with all applicable procedures, standards, and GMP regulations during laboratory testing.
  • Lead investigations for out-of-specification results and other quality events.
  • Provide technical solutions for GMP quality control issues.
  • Support stability programs through timely scheduling and data analysis.
  • Generate and review documentation, including SOPs and protocols for potency assays.
  • Ensure timely review of laboratory data and logbooks.
  • Support LIMS initiatives and ensure analytical performance trending.
  • Maintain a high level of efficiency and accuracy in all testing activities.
  • Prepare for and support Health Authority inspections.
  • Organize and lead QC-related meetings.
  • Collaborate effectively with cross-functional teams.
  • Manage multiple priorities under aggressive timelines while maintaining productivity.
  • Perform additional responsibilities as assigned.

Qualifications:

  • Bachelor's degree in Biology, Biochemistry, or a related scientific discipline.
  • 6-8 years of experience in a Quality Control role within the pharmaceutical industry, with a focus on cell therapy products preferred.
  • Hands-on experience with Cell Based Potency Assays and ELISA platforms.
  • Thorough understanding of ICH/USP/EMA guidelines in a GMP environment.
  • Proven leadership experience in managing scientific teams.
  • Strong technical writing skills for developing test methods and quality documents.
  • Familiarity with laboratory information management systems.
  • Detail-oriented with exceptional technical capabilities.
  • Ability to manage multiple priorities effectively.
  • Proficient in Microsoft Office applications.

Preferred Qualifications:

  • Advanced degree (MSc, Ph.D.) in a relevant scientific field.
  • Experience with multi-color flow cytometry assays.

Physical and Mental Requirements:

  • Ability to wear appropriate clean room attire and personal protective equipment.
  • Must meet requirements for wearing a half-face respirator.
  • Ability to stand and walk for the majority of the workday.
  • Capable of lifting and carrying objects weighing up to 30 pounds.

This position involves working in both an office and laboratory environment, with potential exposure to various chemicals and equipment hazards. Iovance Biotherapeutics Inc is committed to fostering a diverse and inclusive workplace.

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