- Perform experiments in the synthesis, purification, and characterization of small molecules as a part of process investigation, quality by design (QbD) process development, and optimization
- Review and approve cGMP documents, including batch records, change controls, deviations, specifications, validation master plan, and validation protocols/reports
- Support external CDMO activities for drug substance development and manufacturing, including tech transfer, scale-up, process development, and optimization
- Assist in the generation 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 teams 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
- Track progress against project timelines, generate regular status updates, and communicate progress and issues to management, including presentation of findings at team meetings
- Hands-on experience in working in the lab to solve process chemistry issues is highly desired
- Experience with control strategy development and capable of utilizing QbD principles to develop commercially viable manufacturing processes
- Knowledge of 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
- PhD./MS in Organic Chemistry, Chemical Engineering, or related field
- Elevate
- Challenge
- Nurture
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Scientist, Chemical Development - South San Francisco, United States - Alumis
Description
Job Description
Job DescriptionSalary:Alumis Inc. 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 Alumis team is seeking a highly motivated Scientist, in Chemical Development to join the Technical Operations / Chemistry, Manufacturing, and Controls (CMC) team at Alumis. The successful candidate will support process development efforts and oversee activities at contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs).
Responsibilities
The Ideal Candidate
Education
Alumis Values
This position is located in South San Francisco, CA. At this time, we are not considering remote applicants.
Alumis Inc. is an equal opportunity employer.
