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.
- 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.
- 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.