Senior Scientist, Analytical Testing
Bristol Myers Squibb
August 31, 2026
Remote friendly (New Brunswick, NJ)
United States
Operations
Position Summary
- Part of the Analytical Regulated Testing GMP team (Analytical Strategy & Operations). Performs analytical method validation and cGMP activities and provides oversight/strategy to support clinical and commercial development for small molecule New Chemical Entities and Investigational Medicinal Products.
Role & Responsibilities
- Follow GMP/GLP for acquisition/review of data related to method validation/testing of release, stability, and development materials; may guide others.
- Apply phase-appropriate GMP approach in lab work and documentation.
- Coordinate method transfers; manage testing, acceptance of data from contract labs/service providers.
- Maintain laboratory in an “audit ready” status; participate in audits/inspections.
- Support establishment/implementation of corrective actions; prepare/approve method/validation/technology transfer reports.
- Prepare/review SOPs, testing protocols/reports, and training materials.
- Implement laboratory Quality System best practices (training, procedures, instrumentation management, data/records).
- Prepare/approve continuous improvement plans/tools for quality/compliance.
- Identify deviations to quality systems/limits/specifications and ensure timely resolution.
- Lead/participate in investigations and CAPAs.
- Respond to regulatory agency questions related to analytical data/procedures.
- Collaborate with CMC sub-teams to meet API/drug product release/stability and filing timelines.
Qualifications & Experience
- BS in analytical/organic/biochemistry/pharmacy or related + 7+ years industry experience; or MS + 4–6 years; or PhD + 2–4 years.
- Knowledge of IND/NDA validation and troubleshooting of chromatographic separation methods (API and drug product).
- Strong interpersonal communication; interface/influence multidisciplinary teams.
- Experience with regulatory submissions and interactions with inspectors.
- Strong cGMP, regulatory requirements, and ICH compliance knowledge.
Competencies
- Prioritize competing project needs; adapt to change; manage multiple projects/timelines.
- Influence teams; improve efficiency/productivity/quality/compliance.
- Strong verbal/written communication.
Application
- If you’re excited about the role but don’t perfectly match the resume, you are encouraged to apply anyway.
- Part of the Analytical Regulated Testing GMP team (Analytical Strategy & Operations). Performs analytical method validation and cGMP activities and provides oversight/strategy to support clinical and commercial development for small molecule New Chemical Entities and Investigational Medicinal Products.
Role & Responsibilities
- Follow GMP/GLP for acquisition/review of data related to method validation/testing of release, stability, and development materials; may guide others.
- Apply phase-appropriate GMP approach in lab work and documentation.
- Coordinate method transfers; manage testing, acceptance of data from contract labs/service providers.
- Maintain laboratory in an “audit ready” status; participate in audits/inspections.
- Support establishment/implementation of corrective actions; prepare/approve method/validation/technology transfer reports.
- Prepare/review SOPs, testing protocols/reports, and training materials.
- Implement laboratory Quality System best practices (training, procedures, instrumentation management, data/records).
- Prepare/approve continuous improvement plans/tools for quality/compliance.
- Identify deviations to quality systems/limits/specifications and ensure timely resolution.
- Lead/participate in investigations and CAPAs.
- Respond to regulatory agency questions related to analytical data/procedures.
- Collaborate with CMC sub-teams to meet API/drug product release/stability and filing timelines.
Qualifications & Experience
- BS in analytical/organic/biochemistry/pharmacy or related + 7+ years industry experience; or MS + 4–6 years; or PhD + 2–4 years.
- Knowledge of IND/NDA validation and troubleshooting of chromatographic separation methods (API and drug product).
- Strong interpersonal communication; interface/influence multidisciplinary teams.
- Experience with regulatory submissions and interactions with inspectors.
- Strong cGMP, regulatory requirements, and ICH compliance knowledge.
Competencies
- Prioritize competing project needs; adapt to change; manage multiple projects/timelines.
- Influence teams; improve efficiency/productivity/quality/compliance.
- Strong verbal/written communication.
Application
- If you’re excited about the role but don’t perfectly match the resume, you are encouraged to apply anyway.