Senior Scientist, Analytical Testing
Bristol Myers Squibb
August 31, 2026
Remote friendly (New Brunswick, NJ)
United States
Operations
Position Summary
Senior Scientist to support the Analytical Regulated Testing GMP team (Analytical Strategy & Operations). Performs analytical method validation and cGMP activities and provides oversight/strategy for clinical and commercial development for small-molecule New Chemical Entities and Investigational Medicinal Products.
Role & Responsibilities
- Follow GMP/GLP for data acquisition/review related to method validation and testing of release, stability, and development materials; may guide others.
- Apply a phase-appropriate approach to GMP in lab work and documentation.
- Coordinate method transfers; manage acceptance of data from contract labs/service providers.
- Maintain an “audit ready” laboratory; participate in audits/inspections.
- Support corrective actions for findings; prepare/approve method, validation, and technology-transfer reports.
- Prepare/review SOPs, testing protocols/reports, and training materials; implement lab Quality System best practices (training, procedures, instrumentation, data/records).
- Prepare/approve continuous improvement plans; identify deviations and ensure timely resolution.
- Lead/participate in investigations and CAPAs.
- Respond to regulatory questions on analytical data/procedures.
- Collaborate with CMC teams to meet API/drug product release, stability, and filing timelines.
Qualifications & Experience
- BS in analytical/organic chemistry, biochemistry, pharmacy, or related + 7+ years relevant industrial experience; or MS + 4–6 years; or PhD + 2–4 years.
- Knowledge of IND/NDA validation and troubleshooting of chromatographic separation methods for API/drug product.
- Regulatory submission experience and interaction with regulatory inspectors.
- Strong cGMP, regulatory (agency) and ICH compliance knowledge.
Competencies
- Prioritize competing responsibilities; adapt to change; manage multiple projects to timelines.
- Influence teams; improve efficiency/productivity/quality/compliance.
- Strong verbal and written communication.
Compensation & Benefits
- New Brunswick, NJ: $109,270–$132,407 (plus possible discretionary incentive).
- Comprehensive benefits may include medical/dental/vision, life/disability, retirement/financial protection; FTO and holiday benefits (eligibility-based).
Senior Scientist to support the Analytical Regulated Testing GMP team (Analytical Strategy & Operations). Performs analytical method validation and cGMP activities and provides oversight/strategy for clinical and commercial development for small-molecule New Chemical Entities and Investigational Medicinal Products.
Role & Responsibilities
- Follow GMP/GLP for data acquisition/review related to method validation and testing of release, stability, and development materials; may guide others.
- Apply a phase-appropriate approach to GMP in lab work and documentation.
- Coordinate method transfers; manage acceptance of data from contract labs/service providers.
- Maintain an “audit ready” laboratory; participate in audits/inspections.
- Support corrective actions for findings; prepare/approve method, validation, and technology-transfer reports.
- Prepare/review SOPs, testing protocols/reports, and training materials; implement lab Quality System best practices (training, procedures, instrumentation, data/records).
- Prepare/approve continuous improvement plans; identify deviations and ensure timely resolution.
- Lead/participate in investigations and CAPAs.
- Respond to regulatory questions on analytical data/procedures.
- Collaborate with CMC teams to meet API/drug product release, stability, and filing timelines.
Qualifications & Experience
- BS in analytical/organic chemistry, biochemistry, pharmacy, or related + 7+ years relevant industrial experience; or MS + 4–6 years; or PhD + 2–4 years.
- Knowledge of IND/NDA validation and troubleshooting of chromatographic separation methods for API/drug product.
- Regulatory submission experience and interaction with regulatory inspectors.
- Strong cGMP, regulatory (agency) and ICH compliance knowledge.
Competencies
- Prioritize competing responsibilities; adapt to change; manage multiple projects to timelines.
- Influence teams; improve efficiency/productivity/quality/compliance.
- Strong verbal and written communication.
Compensation & Benefits
- New Brunswick, NJ: $109,270–$132,407 (plus possible discretionary incentive).
- Comprehensive benefits may include medical/dental/vision, life/disability, retirement/financial protection; FTO and holiday benefits (eligibility-based).