Senior Scientist, Analytical Testing

Job Summary

Joining the Analytical Regulated Testing GMP team, the full-time Senior Scientist, Analytical Testing will perform analytical method validation and cGMP activities while providing oversight and strategy for clinical and commercial development of small molecule New Chemical entities and Investigational Medicinal Products in New Brunswick, NJ.

Key Responsibilities

• Follows GMP/GLP guidelines for method validation and testing of release, stability, and development materials
• Coordinates method transfers and manages data acceptance from contract laboratories and service providers
• Prepares and reviews operational procedures, testing protocols, and training materials while ensuring laboratory audit readiness

Required Qualifications

• Bachelor's degree in analytical chemistry, organic chemistry, biochemistry, pharmacy, or related field with 7+ years of relevant experience, or a Master's degree with 4-6 years, or a PhD with 2-4 years of experience
• Demonstrated knowledge of IND and NDA validation and chromatographic separation methods
• Experience with regulatory submissions and interactions with regulatory agency inspectors
• Strong understanding of cGMP compliance and ICH requirements
• Excellent interpersonal skills for effective collaboration with multi-disciplinary teams