Associate Director, CMC Analytical Development
- Alumis Inc.
- South San Francisco, CA
- Start date
- Mar 5, 2023
- Information Technology, Business/Data Analytics, Science/R&D, CMC
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Biotech Bay
The small molecule CMC team is seeking highly motivated Associate Director of Analytical Development to help build our dynamic small molecule CMC group at Alumis. The successful candidate will help to manage and drive analytical development and quality control activities from the preclinical phase through late-stage clinical development. Having analytical development expertise and experience in working with CMOs/CTLs, coupled with thorough understanding of the associated quality and regulatory awareness are key assets.
- Manage and drive analytical development and quality control activities for Phase 1 to late-stage drug development
- Manage development, 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
- Oversee release testing and stability studies of drug substance and drug products at CMOs/CTLs, and trend stability and release data using statistical methods
- Identify and characterize drug impurities and degradation products
- Review and approve analytical results, protocols and reports
- Participate, review and approve analytical investigations
- 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 8+ years of experience in analytical development
- Strong leadership, organizational and communication skills
- Comfortable in a fast-paced small company environment and is a strong team player
- Experience in early to late-stage drug development
- Experience in working with CMOs and CTLs
- Experience with analytical techniques for small drug molecules and oral solid formulations required, including UPLC/HPLC, LC-MS, KF, dissolution testing, IR, particle size analysis, and solid-state characterization techniques
- Extensive knowledge in ICH, cGMP and regulatory requirements
- Proven track record in applying analytical techniques to solve challenging problems
• 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 $174,775 USD to $226,539 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.
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Our experienced leadership team brings a proven track record in precision drug development of groundbreaking therapies.
Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer.
With a unique precision analytics platform and an unwavering commitment to advancing our understanding of immunologic diseases, Alumis Inc. will rewrite the autoimmune treatment playbook by developing the right medicine for each patient.
611 Gateway Blvd
South San Francisco
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