Bristol-Myers Squibb Company

Senior Pharmaceutical Microbiologist

Location
New Brunswick, NJ, US
Posted
Nov 23, 2018
Ref
R1509838
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

Responsibilities:
  • 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


Qualifications:
  • 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