A Process Development Engineer designs and implements production systems in manufacturing, engineering or mining. Develops processes that are efficient and cost effective. Plans, implements and tests production systems and processes and ensures compliance with industry and regulatory standards.
Senior Scientist, Chemical Development Employer Alumis Inc. Location South San Francisco Start date Aug 5, 2026 View more categories View less categories Discipline Science/R D , Biotechnology Required Education Masters Degree/MBA Position Type Full time Hotbed Biotech Bay Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details 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 Senior 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).
ESSENTIAL DUTIES & RESPONSIBILITIES
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 the phase appropriate drug substance development. Serve as subject matter expert in chemical development and help drive best practices and technical advancements. Review and approve cGMP documents, including batch records, change controls, deviations, specifications, validation master plan, validation protocols/reports. Draft 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 with functional teams across all levels of the organization. Work in the lab to solve process chemistry issues (20% - 40%) Knowledge of cGMP, ICH, and regulatory requirements
THE IDEAL CANDIDATE
PhD. with minimum of 5 years of experience in small molecule drug substance development, including management of external vendors/CDMOs or MS with minimum of 8 years of experience is desirable Experience with late-stage drug substance technical transfer Experience with control strategy development and capable of utilizing QbD principles to develop commercially viable manufacturing processes 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 (including Asian countries) up to 25% of the time to support ongoing manufacturing activities Bilingual in Japanese/English and able to act as a technical translator for written and verbal communication and technical documents strongly preferred
EDUCATION
PhD. Organic Chemistry, Chemical Engineering, or related field The salary range for this position is $140,000 USD to $160,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices. 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. Alumis Inc. is an equal opportunity employer. Company 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.
Company info Website http:
//www.alumis.com/ Location 611 Gateway Blvd Suite 820 South San Francisco California 94080 US Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Director, Downstream Process Development and Manufacturing Biologics Bridgewater, NJ Lab Automation Scientist Indianapolis, Indiana Principal Process Engineer - API External Manufacturing Small Molecule Indianapolis, Indiana
