Scientist, Formulations
On-site · Indianapolis, Indiana, United States
Job Summary
Formulation Development Scientist to support drug product formulation, process development, and GMP manufacturing for peptide therapeutics; collaborate with CMC, Regulatory, Program teams, CDMOs/CROs; contribute to data review, technology transfer, and regulatory submissions (INDs, NDAs, BLAs, MAAs); perform analytical methods (RP-HPLC, SEC, IEX, CE-SDS, icIEF), support scale-up and process optimization, author memos/protocols/reports, and ensure compliance with GMP/quality documentation; travel to support business needs.
Required Qualifications
- Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related discipline with 1+ years, M.S. with 2+ years, B.S. with 4+ years of relevant industry experience
- Understanding of peptide or protein drug physicochemical characteristics
- Strong expertise in chromatographic, mass spectrometric, and electrophoretic techniques (HPLC/UPLC, LC-MS, CE) including method development and qualification for peptide therapeutics or related modalities
- Prior experience in lyophilization cycle development and process characterization preferred
- Familiarity with end-to-end CMC drug development including critical milestones and typical bottlenecks
- Adherence to Good Documentation Practices (GDocP) and familiarity with electronic lab notebook (ELN)
- Some CMC Regulatory knowledge
- Strong proven problem-solving abilities, with a track record of overcoming complex technical challenges
- Excellent interpersonal and communication skills, with the ability to build strong cross-functional and external partnerships
- Strong organizational skills with the ability to multitask in a dynamic, fast-paced environment and adapt to changing priorities
- Demonstrated ability to meet deadlines, deliver results, and maintain high attention to detail and accuracy
- Travel
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