Principal Scientist, Oral Product Development

Bristol Myers Squibb • New Brunswick, NJ

20h

About The Position

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 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.

Requirements

• Completed BS in Pharmaceutical Science, Chemical Engineering, or related discipline with 9-12 years of pharmaceutical development experience; MS with 6-9 years of experience; or Ph.D. with 4-6 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.

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.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level