Senior Scientist, Analytical Testing & GMP Strategy

Biopharma Careers; New Brunswick (NJ); On-site; USD 109,000 - 132,000; Full time

Benefits offered by this job

Flexible Time Off (FTO)

11 paid company holidays

Comprehensive benefits

Job summary

Bristol Myers Squibb is seeking a Senior Scientist for Analytical Testing in New Jersey. The role focuses on method validation, cGMP compliance, and oversight to support clinical and commercial development of small molecules and IMPs.

You will lead data integrity efforts, coordinate labs, and contribute to regulatory submissions. The position requires strong communication, cross-functional collaboration, and a track record in regulatory environments with IND/NDA experience.

Qualifications

• Bachelor's degree in analytical chemistry, organic chemistry, biochemistry, pharmacy or related field.
• Demonstrated knowledge of IND/NDA validation and troubleshooting of chromatographic separation methods.
• Excellent interpersonal communication skills for interfacing with multi-disciplinary teams.
• Experience with regulatory submissions and interaction with regulatory inspectors.
• Strong knowledge of cGMP, regulatory agency requirements and ICH compliance.

Responsibilities

• Follow GMP/GLP guidelines for data review related to method validation and testing.
• Coordinate method transfers and data acceptance from contract labs.
• Maintain audit-ready laboratory status and participate in audits/inspections.
• Prepare/approve reports for methods, validation, and technology transfer.
• Prepare/review SOPs, testing protocols, and training materials.
• Support CAPA investigations and regulatory inquiries.

Skills

Interpersonal communication

Cross-functional collaboration

Regulatory submissions experience

cGMP knowledge

Education

Bachelor's degree in analytical chemistry or related field

Master's degree in a relevant field

PhD in a relevant field

Job description

Bristol Myers Squibb is seeking a Senior Scientist for Analytical Testing in New Jersey. The role focuses on method validation, cGMP compliance, and oversight to support clinical and commercial development of small molecules and IMPs.

You will lead data integrity efforts, coordinate labs, and contribute to regulatory submissions. The position requires strong communication, cross-functional collaboration, and a track record in regulatory environments with IND/NDA experience.