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Quality Control Manager, Microbiology and Sample Management

2 months ago


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

We are seeking a highly experienced and skilled Quality Control Manager, Microbiology and Sample Management to join our team at Iovance Biotherapeutics, Inc. The successful candidate will be responsible for overseeing the day-to-day microbial quality control operations at our Cell Therapy Center.

Key Responsibilities
  • Manage a team of quality control analysts in the cGMP quality control microbiological testing of in-process and drug product samples for lot release and stability.
  • Lead investigations for laboratory incidents, out-of-specification test results, and corrective and preventive actions.
  • Ensure timely sample distribution in support of quality control internal microbiological testing activities, including sterility, endotoxin, Gram stain, and mycoplasma rapid test methods.
  • Author, review, and approve standard operating procedures, protocols, reports, specifications, and other quality control documents.
  • Coordinate environmental monitoring non-routine sampling for the facility as needed.
  • Support site contamination control programs and qualification/validation/commissioning activities.
  • Support the career development of microbiology team members and establish positive working relationships with internal and external partners.
  • Operate at a consistent and exemplary level of efficiency, producing high-quality and accurate results in a fast-paced environment.
  • Maintain current knowledge of regulations, corporate policies, and industry best practices, trends, and standards to ensure compliance with applicable requirements.
Requirements
  • Bachelor's degree in a relevant discipline (biological sciences or equivalent).
  • Minimum 8 years of experience in the biopharmaceutical industry within a quality control role.
  • Minimum 3 years of experience managing a team.
  • Broad knowledge of biological drug development with respect to quality control.
  • Excellent analytical, written, and verbal communication skills.
  • Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
  • Demonstrate a sense of urgency and ability to recognize time sensitivity.
  • Flexible and adaptable style with an eagerness to take on challenges.
Preferred Qualifications
  • Experience with cell therapy products.
Work Environment

This position will work in both an office and a quality control laboratory setting. The successful candidate must be able to work in a lab setting with various chemical/biochemical exposures, including latex and bleach. The position requires the ability to work in a cleanroom with biohazards, human blood components, and potential exposure to noise and equipment hazards.