Senior Scientist, Formulation Development, Oral Drug Product Development
Bristol Myers Squibb
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.
Job description
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
- 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
- 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.
- 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.
Requirements
- 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.
- 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.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- Retirement benefits
- Financial protection benefits
- Flexible Time Off
- Paid company holidays
- Paid sick leave
- Volunteer days
- Summer hours flexibility
- Global shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.