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Microbiology Program Manager

  1. North West
  1. Contract
Competitive
  1. Compliance / Quality Assurance
07-09-2023
32034
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Microbiology Program Manager – Biopharma – Manchester 

We have a superb opportunity for a QC Manager to join our client, a cell therapy company specialising in immunotherapies in oncology. They are a well-renowned team, with a growing successful portfolio of technology discovery, process development and clinical operations. Due to recent significant investment, this is an exciting time to join our client, participate in their current growth and help them pursue the best treatment for cancer.

Responsibilities
  • Drafting an environmental monitoring (EM) strategic plan for the site and establishing site management endorsement.
  • Maintain EM strategic plan to support current manufacturing schedules and products under GMP conditions.
  • Generating reports for regulatory agencies and responding to inquiries from regulatory authorities.
  • Oversee operations in the QC Microbiology laboratory in support of environmental monitoring and batch related microbiology testing.
  • Oversee growth promotion testing of microbiological media using both ATCC and in-house isolates.
  • Oversee environmental monitoring of the manufacturing areas, including batch related EM, is performed accurately and according to the manufacturing schedule.
  • Draft and execute protocols in support of site contamination control programs, as needed.
  • Oversee the maintenance and build of a microbial identification database for all in-house isolates recovered from the various monitoring programs.
  • Serve as a qualified trainer, provides guidance to other analysts.
  • Support audits and inspections as needed.
  • Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
Requirements
  • Bachelor’s degree in biology, Microbiology or related scientific field is required.
  • Minimum five (5) years of experience in in a cGMP Quality Control microbiology role
  • Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
  • High proficiency in aseptic techniques when executing microbial test methods and environmental monitoring.
  • Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
  • High level of ownership and accountability.
If this role is of interest to you, please apply now!

The candidate must have the rights to work in the location stated in the job advert.

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