We are seeking a Pharmaceutical Microbiologist for an exciting position in a laboratory supporting early and late phase clinical manufacturing. The position is in a dynamic, innovative, professional lab responsible for both aseptic and non-sterile manufacturing support of small molecules and biologics, and provides exciting opportunities to contribute to the development of drugs at the forefront of the industry
- Evaluate and procure rapid microbiology methodologies, and assessing them for application in pharmaceutical manufacturing environments.
- Prepare and execute Installation Operational and Performance qualification protocols for the instrumentation and implementation of new methods.
- Interact with IT groups to assure that the equipment interacts with corporate software and conforms to GMP requirements. Assist in the implementation of a global microbiology environmental monitoring software program.
- Assure timely revision of SOP's, and other procedural documents.
- Complete investigations as they relate to laboratory operations as well as implementation of appropriate CAPAs.
- Draft responses and corrective actions to internal compliance questions related to their work
- Provide guidance and feedback to drug development teams and regulatory functions in responding to health authorities worldwide.
- Serve as a member of interdisciplinary departmental teams, providing scientific and operational input to development plans
- Acquire, review and/or approve in GMP compliant manner, data related to method development and testing of GMP and development materials
- Supervision and training of junior personnel
- Sustain up to date knowledge on applicable department and site standard practices related to GMPs, safety and controlled substances as appropriate to work. Provides input and may author standard practices
- Bachelor Degree in Microbiology or related scientific discipline with 10 to 15 years of experience in pharmaceutical GMP microbiology
- Experience with Rapid Microbiology Methods, Isolator technologies, endotoxin testing, Lean Six Sigma, implementation of electronic notebook technologies and instrument qualifications in a microbiology environment are desired
- Good communication skills, both written and verbal
Ideal Candidate Would Also Have:
- Experience with standard pharmacopeial microbiology tests.
- Experience and/or knowledge of other basic compendial microbial test methods, such as Sterility and Microbial Limits
- Experience conducting laboratory investigations
- Prior participation on cross-functional teams