Senior Scientist, Drug Product Development

2 months ago

South San Francisco, United States Alumis Inc. Full time

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.


Responsibilities


  • Execute and/or oversee pre-formulation activities including characterization of physicochemical and solid-state properties for investigational small molecules.
  • Identify vehicles, excipients, and/or new technologies to support formulation development for preclinical PKPD, efficacy, and tox studies.
  • Execute/oversee formulation and manufacturing process development activities for lead and backup molecules.
  • Write request for proposals and support drug product vendor selection activities.
  • Work effectively with external CDMOs to develop drug products for early-stage development candidates and oversee the production of clinical trial material to support the on-time start of clinical studies.
  • Provide functional area updates (oral and written) clearly and concisely.
  • Author the relevant CMC sections for key regulatory filings including INDs and NDAs.
  • Proactively identify project risks and prepare mitigation and contingency plans.


    The Ideal Candidate


    • Hands-on experience in pre-clinical formulation development working with research to formulate poorly water-soluble compounds.
    • Hands-on experience in HPLC/UPLC analysis and method development is preferred.
    • Experience in formulation development and process optimization for small molecule solid oral dosage forms including modified-release products.
    • Experience in authoring technical reports and regulatory documents (e.g. IND/NDA).
    • Excellent oral and writing communication skills and flexibility to work in a fast-paced team environment.
    • Experience overseeing the production of clinical trial material.
    • Comfortable in a fast-paced small company environment.
    • Willing to travel as needed to support ongoing development activities.


      Education 


      Ph.D. degree in Pharmaceutical Sciences, Chemistry, Engineering or related field with a minimum of 2 years or B.S. or M.S. with a minimum of 5 years related industrial experience.


      Alumis Values


      • Elevate
      • Challenge
      • Nurture


        This position is located in South San Francisco, CA. At this time we are not considering remote applicants.


        The salary range for this position is $165,000 USD to $175,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.   


        Alumis Inc. is an equal opportunity employer.

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