Associate Research Scientist - pharmaceutical microbiology: USA

Bristol-Myers Squibb offers a position of a Associate Research Scientist.

The Responsibilities For The Successful Candidates

  • Provides guidance and feedback to drug development teams and regulatory functions in responding to health authorities worldwide
  • Transfers methods to development and commercial labs around the world
  • Collaborates with formulation and manufacturing colleagues in order to optimize processes and improve productivity.
  • Conducts testing as per assigned technique and methods.
  • Documents work in laboratory notebooks and other systems and as per GMPs and department SOPs.
  • Acquires, reviews and/or approves in GMP compliant manner, data related to methods development and testing of GMP and development materials. Prepares reports for methods, validation, and technology transfer.
  • Sustains 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.
  • Assists in purchase and implementation of new technology
  • Participates in laboratory investigations/inspections.
  • Conducts Microbiology Investigations and implement CAPAs as needed
  • Serves as a member of interdisciplinary development teams, providing scientific and operational input to development plans
  • Drafts responses and corrective actions to internal compliance questions related to their work.
  • Writes and revises SOPs, WIs and Methods as needed.
  • Writes and implement change controls.

The qualified individual will have the following background

  • Bachelor Degree in Microbiology or related scientific discipline with 3 to 7 years experience in pharmaceutical microbiology.
  • Good communication skills, both written and verbal, are required.
  • Experience with bacterial endotoxin test, bioburden and sterility, with in-depth understanding of the method, and possible interferences
  • Experience with instrument qualifications in a microbiology environment is a plus.
  • Knowledge of basic compendial microbial test methods is also a plus.
  • Demonstrated ability to solve non-routine analytical issues and provide guidance to laboratory and external colleagues.
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