- 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
- 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
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Associate Director, CMC Analytical Development - South San Francisco, United States - BioSpace
Description
Job DetailsAlumis 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 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 a thorough understanding of the associated quality and regulatory awareness are key assets.
Responsibilities
• Elevate
• Challenge
• 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 $199,000 USD to $220,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company's compensation practices.
Alumis Inc. is an equal opportunity employer.
