Senior Scientist, Formulation Development, Oral Drug Product Development Full-time NEW

Senior Scientist, Formulation Development, Oral Drug Product Development

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Business Unit Overview Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve patient lives. We leverage the best people, collaboration, and cutting-edge innovation to achieve this commitment. BMS's internal engine of innovation includes unrivaled industry leading expertise in CMC development of small molecules, protein biotherapeutics, protein degraders, and other therapeutic modalities. We collaborate closely with our colleagues in R&D and Commercial to design our drug products. Here, you'll get the chance to grow and thrive through opportunities that are uncommon in scale and scope.

Position Summary Bristol Myers Squibb is seeking a Senior Scientist to join the Oral Product Development group within the Drug Product Development function. The drug product development group supports the formulation and process development of Bristol Myers Squibb's drug candidates from preclinical stage to commercial process readiness. This position is responsible for formulation design, development, characterization, and technology transfer to enable development of small molecule drug products (DPs). The incumbent will be accountable as an individual contributor to support formulation development as well as providing necessary guidance and support of drug product control strategy for drug candidates across all stages of development.

Key Responsibilities The Senior Scientist will collaborate across BMS sites with Drug Product, Analytical, API, Quality, and Regulatory functions to execute drug product formulation/process development, formulation strategies, control strategies, and support of drug application submissions and approval.

• Key member of a dynamic scientifically driven team, dedicated to the design, development, and characterization of robust small molecule drug product formulations.
• Develop oral formulations for clinical studies and commercialization.
• Lead drug product formulation and process development including evaluating the need and potential for enhancing oral bioavailability, stability, and processability of drug candidates through appropriate formulation strategies.
• Support preparation of CMC regulatory documents.
• Support departmental initiatives for assigned projects and methodologies.
• Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.
• Prepare technical reports, batch records, SOPs, publications, and oral presentations as required.
• Collaborate with cross-functional team members to develop and optimize formulations and enable technology transfer to CMOs and other sites for manufacturing and scale up activities.
• Develop, coach and mentor others as appropriate for the position.

Qualifications & Experience

Qualifications:

• Completed BS in Pharmaceutical Science, Chemical Engineering, or related discipline with 7-9 years of pharmaceutical development experience; MS with 4-6 years of experience; or Ph.D. with 2-4 years of experience.

Experience:

• Experienced in formulation development, pharmaceutical processing related to drug product development and hands on experience.
• Fundamental understanding of drug substance, excipients, pharmaceutical unit operations (blending, milling, sieving, granulation, tableting, encapsulation, coating, spray drying), intermediate and critical quality attributes, statistics, risk assessment approaches, and cGMP principles.
• Experienced in building the CMC dossier for regulatory submissions within the development section as an author/reviewer. Basic knowledge of regulatory requirements.
• Demonstrated problem-solving and troubleshooting skills.
• Strong capabilities in experimental design and execution.
• Ability to 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 and interest to serve as a team member/leader in an environment where individual initiative, collaboration, and accountability are valued.
• Organizational and interdepartmental responsibilities with regards to leading workgroups, cross-functional teams, strategy development/ implementation/execution, and cultural initiatives.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.