Senior Scientist, Drug Product Development

Alumis • South San Francisco, CA

2d • Onsite

About The Position

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an experienced and highly motivated Senior Scientist for the Drug Product Development group who can work in a collaborative and dynamic environment. The scientist in this role is responsible for activities critical to the development of Alumis’ molecules including generation of pre-formulation packages, formulation selection, and manufacturing process development. This primary focus of this role will currently be on solid oral dosage form development but may involve the development of other dosage forms in the future.

Requirements

• Ph.D. degree in Pharmaceutical Sciences, Chemistry, Engineering or related field with a minimum of 8 years or B.S. or M.S. with a minimum of 10+ years related industrial experience.
• Hands-on instrumental analysis (HPLC/UPLC, DSC, XRPD) and method development.
• Experience in formulation development, process optimization for small molecule solid oral dosage forms including modified-release products.

Nice To Haves

• Experience in authoring technical reports and regulatory documents (e.g. IND/NDA) is a plus.

Responsibilities

• Hands-on pre-clinical formulation development includes identifying vehicles, excipients, and/or new technologies for poorly water-soluble compounds in support of preclinical PKPD, efficacy, and tox studies.
• Execute and/or oversee pre-formulation activities including characterization of physicochemical and solid-state properties for investigational small molecules with hands-on instrumental analysis (HPLC/UPLC, DSC, XRPD) and method development.
• Work effectively with external CDMOs to develop early-stage drug products and oversee production of clinical trial material in support of clinical timelines.
• Experience in formulation development, process optimization for small molecule solid oral dosage forms including modified-release products includes execute/oversee formulation and manufacturing process development activities.
• Excellent oral and writing communication skills and flexibility to work in a fast-paced team environment by providing updates (oral and written) clearly and concisely.
• Support relevant CMC sections for key regulatory filings including INDs and NDAs. Experience in authoring technical reports and regulatory documents (e.g. IND/NDA) is a plus.
• Comfortable in a fast-paced small company environment. Proactively identify project risks and prepare mitigation and contingency plans.
• Willing to travel as needed to support ongoing development activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 11-50 employees