Director of Quality Control Lab Technical Support

1 day ago


Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Job Title: Director, Quality Control Lab Technical Support

Job Summary:

Iovance Biotherapeutics Inc is seeking a highly experienced Director, Quality Control Lab Technical Support to lead the quality control technical support team in the planning, execution, and documentation of QC co-qualifications, validations, and assay transfers occurring at Iovance's integrated Cell Therapy Center (iCTC). The successful candidate will have a strong background in quality control for biologics and experience in a leadership role.

Key Responsibilities:

  • Direct the QC assay technical team through performance, technical writing, and review of assay transfers, validations, and qualifications with a focus in both analytical and microbiology testing activities.
  • Collaborate effectively with Iovance Development and ASAT teams to perform assay co-qualification, validation, and technical transfer of updated and new assays, as well as potential new products.
  • Provide training support for the QC analytical and microbiological teams.
  • Ensure all technical testing is performed according to company procedures and cGMP.
  • Author, review, and approve technical assay documents including but not limited to protocols, reports, and procedures.

Requirements:

  • Bachelor's degree in a relevant discipline (biological sciences or equivalent)
  • Minimum 12 years of experience in the pharmaceutical industry within a Quality Control role
  • Quality Control laboratory management experience, including management of direct reports.
  • Broad knowledge of quality control for biologics with experience in a leadership role

Preferred Qualifications:

  • Advanced degree (MSc. preferred.)
  • Experience with both analytical and microbiological assays is preferred
  • Experience with cell therapy products is a plus.

Work Environment:

This position will work in both an office and a manufacturing lab setting. When in the lab, you may be exposed to various chemical/biochemical exposures, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers. Able to work in cleanroom with biohazards, human blood components, and chemicals. Potential exposure to noise and equipment hazards and strong odors.

Iovance Biotherapeutics Inc is an equal opportunity employer.



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