Senior Scientist, Analytical GMP & Method Validation

Socket.dev; New Brunswick (NJ); On-site; USD 109,000 - 132,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off (FTO)

Holiday pay

Job summary

Bristol Myers Squibb in New Jersey seeks a scientist for analytical regulated testing in the Analytical Strategy & Operations group. You will perform method validation, ensure cGMP compliance, and provide oversight for API and drug product development through clinical and commercial stages.

Role involves data review, transfer coordination, and collaboration with CMC teams to meet regulatory timelines while maintaining an audit-ready laboratory.

Qualifications

• Bachelor's degree in analytical chemistry, organic chemistry, biochemistry, pharmacy or related field with 7+ years relevant industrial experience or equivalent, or Master's degree and 4-6 years of experience, or PhD and 2-4 years of experience
• Demonstrated knowledge of IND and NDA validation and troubleshooting chromatographic methods used to analyze API and drug product
• Excellent interpersonal communication and ability to interface with multi-disciplinary teams
• Experience with regulatory submissions and interactions with regulatory inspectors
• Strong knowledge of cGMP compliance, regulatory requirements and ICH guidance

Responsibilities

• Follow GMP/GLP guidelines in data acquisition and review for method validation and testing of release, stability, and development materials
• Coordinate method transfers, testing, and data acceptance from contract labs and service providers
• Maintain an audit-ready laboratory and participate in audits and inspections
• Prepare and review reports, procedures, protocols, and training materials
• Lead investigations and CAPA processes with regulatory liaison as needed
• Collaborate with CMC sub-teams to ensure API and drug product release testing meets timelines

Skills

Analytical chemistry

Regulatory interactions

cGMP compliance

Data interpretation

Education

PhD in a relevant field

Master's degree in a related field

Bachelor's degree in analytical chemistry or related

Tools

Chromatography methods

Job description

Bristol Myers Squibb in New Jersey seeks a scientist for analytical regulated testing in the Analytical Strategy & Operations group. You will perform method validation, ensure cGMP compliance, and provide oversight for API and drug product development through clinical and commercial stages.

Role involves data review, transfer coordination, and collaboration with CMC teams to meet regulatory timelines while maintaining an audit-ready laboratory.