Director, CMC Process Chemistry

Employer
Alumis Inc.
Location
South San Francisco, CA
Posted
May 09, 2022
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Contract

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 highly motivated Director of Process Chemistry to help build our dynamic small molecule CMC group at Alumis. The successful candidate will help to lead and drive clinical candidates from the discovery phase through late-stage clinical development. Having extensive process research and development expertise, coupled with thorough understanding of the associated analytical tools, regulatory and quality awareness are key assets.

 


RESPONSIBILITIES

  • Lead and manage all technical aspects of drug substance development, scale-up, and manufacturing at select CRO/CMDO’s around the world
  • Manage external contract manufacturing organizations (CMO’s) and provide technical expertise during technology transfer, conduct process development studies according to the principles of quality by design (QbD), perform specification justification studies to establish limits, perform process characterization studies such as design of experiment (DOE) studies and one variable at a time (OVAT) to identify proven acceptable ranges (PARs) to establish critical process parameters (CPPs), and characterization of API to identify critical process parameters (CQAs). Institutionalize all development activities as source materials for regulatory filings
  • Oversee GMP manufacturing of drug substance at external CMO’s and possess a strong understanding of cGMP’s, as well as firm understanding of regulatory guidances from the ICH, FDA and EU
  • Design chemical development strategy that is phase appropriate and well positioned for accelerated development, and design and execution of validation master plan to support commercialization
  • Work closely with the cross-functional teams to develop the API supply strategy and manage aggressive project timelines
  • Support route scouting activities and innovative process research toward the design and development of efficient, safe, cost-effective processes by applying state-of-the-art chemistry tools and methods to develop new processes when viable
  • Communicate scientific results (oral and written) in a clear and concise manner within cross-functional teams
  • Author CMC sections for regulatory submissions (IND, IMPD, and/or NDA) and patent applications

 

THE IDEAL CANDIDATE

  •  PhD in organic chemistry with minimum 8+ years of experience in the pharamaceutical industry having extensive knowledge of end-to-end CMC DS and DP activities
  • Experienced with managing external vendors, CMO’s, with an understanding of CMC supply chains
  • Experience with solid-state development and characterization is a plus
  • Comfortable in a fast-paced small company environment and is strong team player
  • Extremely well organized and possesses strong analytical skills
  • Excellent interpersonal and communications skills, ability to build productive internal/external working relationships with cross-functional teams
  • Demonstrates knowledge of the overall drug development process
  • Team player is a must and traveling as needed to support ongoing development activities

 

 

Alumis Inc. is an equal opportunity employer. 


If you are hired, we will require you to prove that you have received all CDC-recommended doses of the COVID-19 vaccine or have a valid religious or medical reason not to be vaccinated.