Director, CMC Analytical Development

Employer
Alumis Inc.
Location
South San Francisco, CA
Posted
Jun 28, 2022
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

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 Analytical Development to help build our dynamic small molecule CMC group at Alumis. The successful candidate will help to lead and drive analytical development activities for drug candidates from the preclinical phase through late- stage clinical development. Having extensive analytical development expertise and experience in working with CMOs/CTLs, coupled with thorough

understanding of the associated quality and regulatory awareness are key assets.


RESPONSIBILITIES

  • Lead and manage analytical development and quality control activities for Phase 1 to late stage drug development
  • Manage validation and transfer of analytical methods to support starting material, intermediate, drug substance and drug product testing at CMOs/CTLs
  • Establish and justify specifications for drug substances, starting materials, intermediates and drug products
  • Identify and characterize drug impurities and degradation products
  • Perform analytical method development for drug substances and drug products, including in-process control methods, and characterize physical and chemical properties of drug candidates
  • Oversee release testing and stability studies of drug substances and drug products at CMOs/CTLs, and trend stability and release data using statistical methods
  • Review and approve analytical results, protocols and reports
  • Support evaluation of packaging configurations of oral solid dosage forms
  • Collaborate with CMC team, QA and CMOs/CTLs towards timely generation and approval of documents
  • Communicate scientific results (oral and written) in a clear and concise manner within cross-functional teams
  • Author technical reports and documents in support of regulatory filing
  • Prepare CMC documents for IND, IMPD and NDA


THE IDEAL CANDIDATE

  • MS or PhD in chemistry or pharmaceutical sciences with minimum 12+ years of experience in analytical development
  • Strong leadership, organizational abilities and communication skills
  • Comfortable in a fast-paced small company environment and is a strong team player
  • Experience in late stage drug development
  • Experience in working with CMOs and CTLs
  • Expert knowledge in ICH, cGMP and regulatory requirements
  • Proven track record in applying analytical techniques to solve challenging problems
  • Experience with analytical techniques for small drug molecules and oral solid formulations required, including UPLC/HPLC, LCMS, GC, KF, dissolution testing, UV/Vis, IR, particle size analysis, and solid-state characterization techniques


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


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.