Careers
Job Posting: Manager, Microbiology
Indianapolis, IN
Full Time
Position Overview
Responsible for managing and setting the direction of the QC Laboratory operations (Microbiology) in a cGMP environment. Main responsibility is to assure the reliability of all data generated by the Quality Control Laboratory, and provide support for the Sites environmental monitoring program.
Major Responsibilities
- Supervision, training and development of reporting QC Microbiology staff, and provide guidance on best aseptic practices for all aseptic 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, 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 eight years of experience in a pharmaceutical 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.
If you are an employee who meets the requirements and wish to be considered for the above position, please complete the Internal Position Application and attach a copy of your resume then submit both documents to Human Resources by the above closing date to be considered.
