CMCPM Radiopharmaceuticals
Eli Lilly and CompanySalary not specified
Full Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Sr Scientist - Radiopharmaceutical Development & CMC at Bristol-Myers Squibb
Indianapolis, Indiana, United States
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, OncologyIndustries
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
Skills
Radiopharmaceutical Development
CMC
Preclinical Development
Drug Product Optimization
Radioisotopes
Chemistry
Manufacturing
Process Development
Scientific Experimentation
Bristol-Myers Squibb
Develops and delivers biopharmaceutical medicines
About Bristol-Myers Squibb
Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.
New York City, New YorkHeadquarters
1887Year Founded
$33,706.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees