WORKING WITH US

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

BUSINESS UNIT SUMMARY:

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 principal 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 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.

QUALIFICATIONS & EXPERIENCE

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.

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.