Senior Manager, Chemical Development
The small molecule CMC team is seeking a highly motivated Senior Manager of Chemical Development who will be responsible for development and manufacturing activities critical to the successful development for the lead program at Alumis.
Annually: USD 165000 - 185000
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South San Francisco, California, United States
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 Senior Manager of Chemical Development who will be responsible for development and manufacturing activities critical to the successful development for the lead program at Alumis. The successful candidate will be able to oversee contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) as well as lead process development efforts in preparation for successful late-stage manufacturing.
- · Drive CDMO activities for late-stage drug substance development and manufacturing, including tech transfer, scale-up, process development, and optimization.
- · Provide technical guidance and oversight (both internally and externally) to drive phase-appropriate drug substance development.
- · Serve as subject matter expert in chemical development and help drive best practices and technical advancements.
- · Establish control strategy and apply principles of quality by design (QbD) to identify critical quality attributes (CQA) and to execute design of experiment (DOE) studies intended to identify proven acceptable ranges (PARs) and establish critical process parameters (CPPs).
- · Review and approve cGMP documents, including batch records, change controls, deviations, specifications, validation master plan, validation protocols/reports.
- · Author the CMC sections of regulatory filings, including IND/IMPDs and NDA/MAAs
- · Document development activities as source reports for regulatory filings.
- · Work effectively with the cross-functional CMC team to ensure timely delivery of drug substance throughout the full drug lifecycle.
- · Implement best practices and drive continuous improvements in the drug substance development process through technology innovation and problem solving.
- · Proactively identify risks and communicate effectively to functional teams across all levels of the organization.
THE IDEAL CANDIDATE
- · PhD./MS in Organic Chemistry, Chemical Engineering, or related field
- · Minimum of 5 years of industry experience with PhD (minimum of 8 years of experience with MS) in small molecule drug substance development, including management of external vendors/CDMOs
- · Hands-on experience in working in the lab to solve process chemistry issue is highly desired.
- · Experience with control strategy development and capable of utilizing QbD principles to develop commercially viable manufacturing processes
- · Strong knowledge in cGMP, ICH, and regulatory requirements
- · Highly proficient oral and written communication abilities
- · Excellent collaboration, problem-solving, and organizational skills
- · Comfortable in a fast-paced small company environment
- · Ability to travel domestically and internationally up to 25% of the time to support ongoing manufacturing activities
- · 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 $165,000 USD to $185,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.
6 months ago