Position Summary
The Senior Research Associate, Drug Product Development, will support drug product formulation development from early preclinical enabling studies through clinical supply for First-in-Human (FIH) trials. Hands-on lab execution, data analysis, and technical documentation for oral and/or parenteral dosage forms. Works with formulation, analytical, DMPK, toxicology, and manufacturing teams.
Essential Job Functions And Responsibilities
- Perform hands-on formulation development for preclinical and early clinical drug products, including FIH studies.
- Prepare and evaluate formulations for in vivo (PK, tox) and clinical use.
- Execute experiments including formulation preparation, characterization, and stability testing.
- Maintain accurate experimental records in electronic laboratory notebooks (ELNs).
- Support scale-up, tech transfer, and manufacturing activities for clinical supplies.
- Assist in preparation of protocols, reports, and CMC documentation for regulatory submissions.
- Collaborate cross-functionally with analytical, DMPK, toxicology, quality, and external partners/CDMOs.
- Troubleshoot formulation/manufacturing challenges; propose solutions.
- Ensure compliance with internal procedures and applicable GMP/GxP requirements as needed.
Education And Experience
- Bachelorβs or Masterβs in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
- 3β5 years formulation development experience with hands-on lab experience.
- Preclinical and/or clinical formulation development experience, ideally through FIH.
Skills/Qualifications
- Oral and/or parenteral formulation experience; knowledge of common techniques/excipients.
- Strong organization, attention to detail, lab execution, and problem-solving.
- Ability to work with minimal supervision; strong communication and presentation.
- Ability to author/review development reports; collaborate cross-functionally; manage multiple priorities.
Additional
- Biology/chemical lab environment experience; EHS requirements apply.
- Travel up to 5%.
Benefits/Compensation (as stated)
- Salary range: $82,000β$103,000.
- Total rewards may include discretionary annual target bonus, stock options, ESPP, 401k match, health insurance, 20 PTO days, 10 paid holidays, and winter shutdown.