Supervisor, Quality Control, Microbiology Specialist
6 days ago
We are seeking a highly skilled and experienced Supervisor, Quality Control, Microbiology to join our team at Iovance Biotherapeutics, Inc. This is a critical role that requires a strong background in microbiology and quality control, as well as excellent leadership and communication skills.
Key Responsibilities- Oversee the daily operations of the QC Microbiology laboratory, ensuring compliance with cGMP regulations and company policies.
- Perform routine microbiological testing and environmental monitoring of the cleanroom areas, as well as schedule and perform gas sampling as required.
- Lead a team of analysts in performing data analysis and result reporting of microbiology assays, ensuring timely and accurate product lot release.
- Develop and execute protocols in support of site contamination control programs, as well as maintain and build a microbial identification database for in-house isolates.
- Collaborate with contract labs and vendors to ensure timely and accurate testing, and work closely with the Sterility Assurance team to analyze and report environmental monitoring data.
- Provide guidance and training to analysts, and mentor and support career development of direct reports.
- Initiate and investigate deviations, and support audits and inspections as needed.
- Bachelor's degree in Biology, Microbiology, or related scientific field.
- Minimum five years of experience in a cGMP Quality Control microbiology role, with prior experience in managing a team and having direct reports.
- Strong technical writing skills, with experience in writing protocols, deviations, investigations, and SOPs.
- Ability to effectively manage multiple priorities and work in a fast-paced environment.
- High level of ownership and accountability, with a strong commitment to quality and compliance.
- Experience with cell therapy products.
This position will work in both an office and a manufacturing lab setting, with potential exposure to noise and equipment hazards, strong odors, and biohazards. The successful candidate must be able to work in a cleanroom environment and wear appropriate personal protective equipment (PPE).
Iovance Biotherapeutics, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a workplace that is inclusive and respectful of all employees, and we strive to provide a work environment that is free from discrimination and harassment.
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