Principal Scientist, Oral Product Development

Role Summary

Bristol Myers Squibb is seeking a principal scientist to join the Oral Product Development group within the Drug Product Development function. 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 and as a formulation matrix team lead 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.

Responsibilities

• The Principal 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.

Qualifications

• Required: Completed BS and minimum of 9 years; MS and minimum of 6 years; or Ph.D. and minimum of 4 years in Pharmaceutical Science, Chemical Engineering or related discipline with pharmaceutical development experience.
• Experienced in formulation development, pharmaceutical processing related to drug product development and hands on experience.
• Strong 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.