Reporting to the Senior Vice President, the Principal Scientist will join the Product Development team at a commercial-stage biopharmaceutical company to develop innovative formulations for injectable drug products.
Day to Day:
- Lead the development of innovative formulations for injectable and parenteral products for small molecules and peptides
- Author protocols and reports in addition to CMC regulatory documents
- Develop analytical methods using HPLC and LC-MS for product characterization
- Collaborate with and lead tech transfer to external vendors for drug product development and manufacturing
- Represent the CMC team in project meetings
Requirements:
- Post-doctoral training with 1 year of industry experience in a GMP setting OR MS with 5+ years of GMP industry experience
- Experience with injectable drug products using small molecules or peptides, including complex and combination products
- Strong knowledge of analytical instrumentation (HPLC and LC-MS)
- Ability to work in a quick-paced environment
