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Sr. Research Investigator/ Scientist

Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: February 15, 2019

Job Description:

The successful candidate will be part of the Analytical Regulated Testing GMP team at BMS New Brunswick New Jersey within Analytical Strategy & Operations. Responsibilities include conducting and overseeing cGMP analysis and analytical method validations. The responsibilities of a Project Coordinator (PC) provides strategy and oversight to analytical cGMP activities to support clinical and commercial development for small molecule New Chemical entities and Investigational Medicinal Products.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 or MS degree in analytical chemistry, organic chemistry, biochemistry or Pharmacy with more than 8 years relevant industrial experience or equivalent.
    • Demonstrated knowledge of 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.

        Keywords: Bristol-Myers Squibb Company, New Brunswick , Sr. Research Investigator/ Scientist, Other , New Brunswick, New Jersey

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