Senior Principal Scientist, Drug Product Development

Bristol-Myers Squibb • Summit, NJ

404d • Hybrid

About The Position

The Senior Principal Scientist in Drug Product Development at Bristol Myers Squibb is responsible for leading the formulation design, development, and technology transfer of small molecule drug products. This role involves collaboration across various functions to ensure the successful development of drug candidates from preclinical stages to commercial readiness, with a focus on enhancing oral bioavailability and stability.

Requirements

• Completed BS in Pharmaceutical Science, Chemical Engineering, or related discipline with 12-15 years of pharmaceutical development experience; MS with 9-12 years of experience; or Ph.D. with 6-8 years of experience.
• Experienced in oral formulation development on multiple projects and for different clinical phases, with hands-on experience.
• Advanced understanding of drug substance, excipients, pharmaceutical unit operations, and cGMP principles.
• Experienced in building the CMC dossier for regulatory submissions as an author/reviewer.
• Demonstrated problem-solving and troubleshooting skills.
• Strong capabilities in experimental design and execution.
• Ability to multitask and work independently.
• Ability to provide leadership, guidance, and training to others within the department.
• Strong verbal and written communication skills.
• Strong interpersonal skills and the ability to serve as a team member/leader.

Nice To Haves

• Experience in oral formulation commercialization.

Responsibilities

• Collaborate across BMS sites with Drug Product, Analytical, API, Quality, and Regulatory functions to execute drug product formulation/process development.
• Develop oral formulations for clinical studies and commercialization.
• Lead drug product formulation and process development, enhancing oral bioavailability, stability, and processability of drug candidates.
• Act as a prime technical contact requiring cross-functional coordination inside and outside the department.
• Train others and serve as a technical point of contact within the group and other departments.
• Lead/support preparation of CMC regulatory documents.
• Initiate continuous improvement or development of new approaches/technologies within or across departments/functions.
• Maintain safety, regulatory, and compliance standards related to pharmaceutical development.
• Prepare/review technical reports, batch records, SOPs, publications, and oral presentations.

Benefits

• Competitive salary and benefits package
• Opportunities for professional growth and development
• Flexible work environment
• Diversity and inclusion initiatives
• Health and wellness programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree