Senior Scientist, Drug Product Development
Location: South San Francisco
Posted on: June 23, 2025
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Job Description:
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.
Keywords: , Santa Rosa , Senior Scientist, Drug Product Development, Science, Research & Development , South San Francisco, California
