microbiologists

Major Responsibilities:

Supervision, training and development of reporting QC Microbiology staff, and provide guidance on best aseptic practices for all aseptic (Sterile) area personnel.

Management of the Environmental Program, as backup to the Site Microbiologist.

Trend analysis and evaluation of critical system data; this may include environmental monitoring reports.

Management adherence to the budget for the Microbiology Laboratory.

Responsible for Environmental, Health, and Safety compliance

Communication with manufacturing, aseptic facilities, and external department staff on microbiological and environmental operational issues

Provide support for all environmental excursions at the Site, with identification of root cause and effective CAPA. This also includes media fill and sterility failure investigations.

Serve as reviewer of facility, equipment and product test data and reports

Represent QC laboratory in a technical expert capacity on microbiological method qualifications, special studies and validations when required.

Manage and coordinate new product bioburden, sterility, endotoxin and sub-visible particulate method qualifications for new CDMO clients.

Performs special projects and other duties as assigned.

Requirements:

Minimum of a B.S. degree with a major in Microbiology. (Masters degree preferred)

Minimum of 8 years of experience in a pharmaceutical aseptic manufacturing environment

Minimum of 5 years as a Microbiological laboratory supervisor in a pharmaceutical manufacturing environment or 4 years of microbiological laboratory experience and a higher degree in Microbiology.

Knowledge of QC systems operations, GMP testing/manufacturing environment expertise, microbiological method validation.

Microbiology and environmental systems operations experience in an aseptic environment is requirement.