Bristol-Myers Squibb Company

Senior Pharmaceutical Microbiologist

New Brunswick, NJ, US
Sep 19, 2018
Required Education
Bachelors Degree
Position Type
Full time
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