Sr Scientist - Radiopharmaceutical Development & CMC

Bristol Myers Squibb • Indianapolis, IN

51d • Onsite

About The Position

We are seeking a highly motivated Sr. Scientist to lead the development and optimization of radiopharmaceutical drug products and radioisotopes. This position plays a pivotal role in driving preclinical development of innovative drug products aimed at treating various cancers. The successful candidate will contribute to shaping and advancing our Chemistry, Manufacturing, and Controls (CMC) strategy

Requirements

• Ph.D., M.S., or B.S. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field, with requisite industry experience.
• 5+ years of experience in drug development, manufacturing, CMC or related fields in a pharmaceutical industry, preferably radiopharmaceuticals.
• Strong understanding of GMP, FDA/EMA regulations, and ICH guidelines.
• Strong problem-solving abilities and the ability to manage multiple projects in a fast-paced environment.
• Excellent project management and cross-functional collaboration skills.
• Excellent technical writing skills.

Responsibilities

• Design, plan and execute scientific experiments for pre-clinical development of radiopharmaceuticals.
• Drive CMC process development and optimization for clinical drug products, including formulation lock and robust process definition, ensuring scalability and compliance with regulatory standards
• Design, plan and execute scientific experiments for scale up and automation of drug products and API manufacturing processes.
• Interpret complex experimental data, draw scientifically rigorous conclusions, and communicate findings in technical reports, regulatory documentation, and presentations for internal and external stakeholders
• Author technical reports and source documents to support regulatory filing.
• Author CMC sections for IND/NDA for FDA submissions, and support regulatory filing in other jurisdictions, e.g. EMA, Health Canada, etc.
• Support technology transfer of drug products and API from preclinical stage to clinical manufacturing.
• Collaborate cross-functionally with Regulatory, Quality, Supply Chain, Clinical, and R&D teams to ensure alignment with corporate goals
• Manage and prioritize research projects, oversee third-party vendors, and mentor junior scientists and associates
• Provide support for commercialization of radiopharmaceuticals
• Up to 20% of travel required

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees