Associate Director, Quality Control, Sterility Assurance

4 weeks ago


Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full time

About the Role:

Iovance Biotherapeutics, Inc. is seeking a highly motivated Associate Director, Quality Control, Sterility Assurance to join our team. As a key member of our Quality Control department, you will be responsible for assisting in the development and oversight of microbial contamination control processes and procedures.

Key Responsibilities:

  • Collaborate with multiple stakeholders to ensure harmonized execution of contamination control policies across two manufacturing sites.
  • Support new product transfers related to contamination control aspects of manufacturing process and equipment design.
  • Develop and maintain microbial contamination/Cross contamination risk assessment (HACCP).
  • Establish and implement appropriate training programs in collaboration with training leads.
  • Provide justification or reports to address any finding for Microbiology (EM program, CCS, or Safety Methods) for any Regulatory Audits or Filings.

Requirements:

  • Bachelor's degree in a relevant discipline (biological sciences or equivalent).
  • Minimum Ten (15+) years of experience in the pharmaceutical industry within a Quality Control microbiology role.
  • Demonstrate knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology.

What We Offer:

Iovance Biotherapeutics, Inc. is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.



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