Bristol-Myers Squibb Company

Principal Scientist

Location
New Brunswick, NJ, US
Posted
Oct 06, 2018
Ref
R1510276
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Responsibilities include but limited to:
  • Effective collaboration and communication with the Integrated Development Team ensuring all API and drug product release testing, stability testing and filing requirements meet associated clinical timelines
  • Management of all analytical cGMP requirements from Phase I through Registrational filing to ensure project deliverable timelines are met.
  • Provide technical expertise for evaluation and feedback of methods Provide technical expertise and troubleshooting for technical problems and investigations
  • Participate in the preparation and the critically review of regulatory filings including evaluation of data from collaborator labs.
  • Technology transfer of analytical methods to external BMS partners.
  • Provides input into audit readiness and expertise for Internal and regulatory inspections.


Qualifications/experience:
  • PhD in analytical chemistry, organic chemistry, biochemistry or Pharmacy with relevant industrial experience or equivalent is preferred.
  • Demonstrated knowledge and experience in the IND and NDA validation and troubleshooting of chromatographic separation methods used to analyze API and drug product.
  • Excellent interpersonal communication skills with capability of interfacing with and influencing multi-disciplinary teams.
  • Experience with regulatory submissions and interaction with regulatory agency inspectors.
  • Demonstrate a strong knowledge of cGMP compliance, regulatory agency requirements and ICH compliance.

Competencies:
  • Demonstrates ability to prioritize project responsibilities to effectively assign and manage resources across the team to meet competing requirements.
  • Ability to adapt to change, manage multiple projects effectively meeting timelines.
  • Able to influence teams and seek opportunities to develop new and different ways to resolve project challenges.
  • Able to identify opportunities and implement solutions to improve efficiency, productivity and quality/compliance.
  • Strong verbal and written communication skills to effectively communicate with key partners both internally and externally.