Principal Scientist/Senior Principal Scientist – Analytical Testing
| Company | Bristol Myers Squibb |
|---|---|
| Location | Edison, NJ, USA |
| Salary | $124520 – $164700 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- Bachelors degree in analytical chemistry, organic chemistry, biochemistry, pharmacy or related field with 9+ years relevant industrial experience or equivalent, or Masters degree and 6-9 years of experience, or PhD and 4-6 years of experience
- Bachelors degree in analytical chemistry, organic chemistry, biochemistry, pharmacy or related field with 12+ years relevant industrial experience or equivalent, or Masters degree and 9-12 years of experience, or PhD and 6-8 years of experience
- Demonstrate knowledge of the IND and NDA validation and troubleshooting of chromatographic separation methods used to analyze API and drug product
- Experience with GMP testing and notebook review
- Demonstrate a strong knowledge of cGMP compliance, regulatory agency requirements, ICH guidance
Responsibilities
- Performs analytical cGMP test activities and provide technical expertise for evaluation and feedback of methods
- Provides technical expertise and troubleshooting for technical problems and investigations
- Participates 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
- Effective collaboration and communication with the CMC sub teams to ensure all API and drug product release testing, stability testing and filing requirements meet associated clinical timelines.
Preferred Qualifications
- Advanced degree (MS or PhD) are preferred but not mandatory