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, Chemical Development to join the Technical Operations / Chemistry, Manufacturing, and Controls (CMC) team at Alumis. The successful candidate will support process development efforts as well as oversee activities at contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs).
RESPONSIBILITIES
- 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
THE IDEAL CANDIDATE
- PhD/MS with 3+ years of experience in chemistry or pharmaceutical sciences is desirable
- Hands-on experience in working in the lab to independently 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
- Strong presentation skills highly desired
- 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
EDUCATION
- PhD/MS in Organic Chemistry, or related field
The salary range for this position is $140,000 USD to $150,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. Lab personnel, however, are generally onsite 4-5 days/week. At this time we are not considering remote applicants.Alumis Inc. is an equal opportunity employer.Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.
Other benefits include:
- Health insurance premiums paid at 90% for employee, 80% for dependents
- Free access to Genentech Bus & Ferry Share program
- $100 monthly cell phone stipend
- Unlimited PTO for Exempt employees
- Free onsite gym and a kitchen stocked with yummy snacks and drinks!
We are a hard-working, collaborative team on a mission to transform patient’s lives-- and we aspire to elevate, challenge and nurture one another along the way.
