Director of Quality Control Lab Technical Support
1 day ago
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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