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AlumisSee more

addressAddressSouth San Francisco, CA
type Form of workFull-Time
CategoryInformation Technology

Job description

Job Description

Salary:

Alumis 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.


The small molecule CMC team is seeking a highly motivated Scientist for the Drug Product Development group who can work collaboratively with good communication skills in a dynamic team. Responsibilities include activities critical to the development of Alumis’ molecules including (1) leading preformulation characterization and formulation development to enable preclinical PKPD/tox studies and compound selection to advance to the FIH study, (2) clinical stage formulation and manufacturing process development, (3) support IND Module 3 filing.  The primary focus of this role will be on solid oral dosage form development but may involve the development of other dosage forms in the future. 


KEY RESPONSIBILITIES


  • Execute and/or oversee preformulation activities including physicochemical and solid-state properties for investigational small molecules such as solubility, solid and state stability, particle size and morphology, bio-relevant dissolution, and polymorphism.
  • Select vehicles, excipients and/or new technologies appropriate to prepare formulations to enable preclinical PKPD and tox studies, with desired stability.
  • Prepare request for proposals and support drug product vendor selection activities.
  • Work closely with external CDMO’s to develop Phase 1 drug products for early-stage development candidates.
  • Provide functional area updates (oral and written) in a clear and concise manner.
  • Oversee the production of clinical trial material production to support on-time start of clinical studies.
  • Support the authoring and review IND Module 3 drug product section for regulatory submission.
  • Participate in managing in-house laboratory including common & material supply for formulation development and lab compliance to regulated safety/hazardous requirement.


QUALIFICATIONS


  • D. degree in Pharmaceutical Science, Chemistry, or related field with minimum of 2 years’ experience or B.S. or M.S. with a minimum of 4 - 5 years related industrial experience
  • Hands-on experience in pre-clinical formulation development working with discovery research to formulate poorly water-soluble compounds to maximize exposure
  • Hands-on experience in HPLC/UPLC analysis and method development is preferred.
  • Experience in formulation development for small molecule oral dosage forms
  • Experience in supporting the authoring of development/technical reports and INDs or related regulatory documents a plus
  • Excellent oral and writing communication skills
  • Ability to prepare technical correspondence and present to research, CMC, and department meetings.
  • Experience with overseeing the production of clinical trial material to support on-time start of clinical studies is a plus
  • Comfortable in a fast-paced small company environment
  • Willing to travel as needed to support ongoing development activities


Alumis Values

  • We Elevate
  • We Challenge
  • We Nurture

 


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

 

The salary range for this position is $120,000 USD to $140,000 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. 

 

If you are hired, we will require you to prove that you have received the primary series of an FDA-approved or authorized COVID -19 vaccine and at least one booster or have a valid religious or medical reason not to be vaccinated.

 



Refer code: 2378987. Alumis - The previous day - 2023-02-05 23:30

Alumis

South San Francisco, CA
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