Microbiologist

  • location: Libertyville, IL
  • type: Permanent
  • salary: $70,000 - $95,000 per year

job description

Senior Quality Control Microbiologist

Libertyville

Responsibilities:

  • Manage the transfer and provide technical oversight of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability).
  • Establish user requirements for purchase, qualification of QC equipment and work with internal and external resources to maintain equipment in an optimal state.
  • Develop, revise and review SOPs, qualification/validation protocols and reports.
  • Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures.
  • Monitor the GMP systems currently in place to ensure compliance with documented policies.
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
  • Gather metric information for use in continuous improvement of areas of responsibility.
  • Train staff on technical concepts and methods.
  • Review laboratory data.
  • Perform other duties as assigned.

Qualifications:

  • Bachelor's degree or advanced degree in Microbiology or related discipline.
  • A minimum of 8 years' experience working in a GMP QC Microbiology laboratory, preferably in an aseptic processing facility. A minimum of 3 years' experience with method and equipment validation within the biotechnology or pharmaceutical industry.
  • The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
  • The ideal candidate is well versed in various microbiological techniques including rapid release methods (Bac-T, PTS, MCS), and qualifying environmental monitoring processes with reference to cell and gene therapy products.
  • Strong knowledge of Environmental Monitoring equipment, requirements and tests (viable and non-viable), Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/1271, ISO 14644-1, USP, EP).

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