Senior Scientist, Drug Product Development

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 will be responsible for activities critical to the development of Alumis’ molecules including formulation and manufacturing process development, activities leading to commercialization. This primary focus of this role will currently be on supporting late-stage small molecule drug product development activities in preparation for process performance qualification.

Responsibilities

• Conduct design of experiment (DoE) studies for process optimization, perform characterization to evaluate relevant product attributes, data analysis, and author reports
• Support registration stability and process validation activities up to and including the initial process performance qualification
• Work effectively with external CDMO’s on the execution of PPQ activities, including risk assessment, qualification protocols, and validation reports
• Oversee the production of clinical trial material to support on-time start of clinical studies and to ensure uninterrupted supplies for ongoing studies
• Implement innovative and state-of-the-art technologies to support efficient and cost-effective processes and drug product manufacturing
• Contribute to CMC sections of regulatory submissions (e.g. NDA) by authoring technical sections including justification of manufacturing processes and addressing any regulatory requests for information
• Provide functional area updates (oral and written) in a clear and concise manner
• Proactively identify project risks and prepare mitigation and contingency plans
• Travel as needed to support ongoing development activities (est. up to 25% travel)
  
  

THE IDEAL CANDIDATE

• Experience with late-stage development of oral solid dosage forms including process validation
• In-depth knowledge of solid oral dosage form formulation including immediate-release and modified-release products. Experience in phase appropriate formulation development and process optimization
• Understanding of current good manufacturing practice (cGMP), adept with state-of-the-art drug product development strategies, and capable of utilizing quality by design (QbD) concepts
• Experience with late-stage pharmaceutical development process including scale-up, transfer to commercial manufacturing facility
• Familiarity with packaging configurations, stability study design and physical/chemical stability a plus
• Ability to work independency with minimal supervision and work in cross functional team
• Experience in authoring technical reports and regulatory documents (e.g. NDA, MAA, PAS, and CBE)
• Excellent verbal and written communication skills and flexibility to work in a fast-paced team environment.
• Comfortable in a fast-paced small company environment
  
  

EDUCATION

• PhD. degree in Pharmaceutical Sciences, Chemistry, Engineering or related field with minimum of 4 years or M.S. with a minimum of 6 years or B.S. degree with a minimum of 8 years related industrial experience
  
  

The salary range for this position is $160,000 USD to $170,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

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