Senior Scientist, Drug Product Development
Alumis
Responsibilities:
- Hands-on pre-clinical formulation development: identify vehicles, excipients, and/or new technologies for poorly water-soluble compounds to support preclinical PK/PD, efficacy, and tox studies.
- Execute and/or oversee pre-formulation activities, including characterization of physicochemical and solid-state properties using hands-on instrumental analysis (HPLC/UPLC, DSC, XRPD) and method development.
- Work with external CDMOs to develop early-stage drug products and oversee production of clinical trial material in support of clinical timelines.
- Formulation development and process optimization for small-molecule solid oral dosage forms, including modified-release products; execute/oversee formulation and manufacturing process development.
- Provide clear oral and written updates; flexible in a fast-paced team environment.
- Support CMC sections for regulatory filings including INDs and NDAs; authoring technical reports and regulatory documents is a plus.
- Proactively identify project risks and prepare mitigation/contingency plans.
- Travel as needed.
Qualifications:
- Ph.D. in Pharmaceutical Sciences, Chemistry, Engineering, or related field with 8+ years of experience; or B.S./M.S. with 10+ years related industrial experience.
Education:
- Ph.D., B.S., or M.S. in relevant fields (as above).