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
- 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
- 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
Education
PhD. / MS in Organic Chemistry, Chemical Engineering, or related field
Alumis Values
- Elevate
- Challenge
- Nurture
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.
Scientist, Chemical Development (Contract)
The successful candidate will support process development efforts and oversee activities at contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs). The Alumis team is seeking a highly motivated Scientist, in Chemical Development to join the Technical ...
Scientist, Chemical Development (Contract)
The successful candidate will support process development efforts and oversee activities at contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs). The Alumis team is seeking a highly motivated Scientist, in Chemical Development to join the Technical ...
Associate Director/ Sr Scientist, Chemical Development
The candidate will be responsible for chemical development-related activities across the portfolio including process development and manufacture of regulatory starting materials (RSMs) and support production of Drug Substance (DS) for clinical trial materials, and establishment of associated Control...
Scientist, CMC Analytical Development (Contract)
The Alumis team is seeking a highly motivated Contract Scientist of Analytical Development to join our dynamic small molecule CMC analytical group. Provide analytical support for both in-house and outsourced CMC development activities, such as analytical method development, method transfers and vali...
Associate - PhD
Cornerstone Research provides Associates with opportunities to use theoretical and empirical research skills gained through their. Associates work closely with senior staff, clients, and experts to define objectives, guide research efforts, manage deadlines, and mentor junior staff. Associates conti...
Business Data Analyst
Scale is looking for a Business Data Analyst to join our Analytics team to help advance AI development. The ideal candidate has a strong technical background, is talented at turning data into actionable insights, and can work effectively with stakeholders across the company. Translate intricate data...
$250/hour Paid Market Research Study for IT Project Managers in the Healthcare Sector
CEO, COO, CMO, CFO, CTO, SVP IT, VP IT, SVP Sales, VP Sales, SVP Marketing, VP Marketing, SVP Ops, VP Ops, SVP HR, VP HR, SVP Finance, VP Finance, IT Leader, IT Manager, IT Director, Senior IT Manager, IT Administrator, IT Project Manager, IT Supervisor, Software Development Executive, Software Deve...
Bioscience Research Associate I - Sleep Lab
The Human Sleep Research Lab, in the Center for Health Sciences, is seeking highly motivated research associates to support several NIH-sponsored projects about adolescent brain development (e. Bioscience Research Associate I - Sleep Lab. The Research Associate will be responsible for:. If you're lo...
Junior Data Analyst
Key Responsibilities:Data Delivery AnalysisData Quality AnalysisCRM Data Migration and SupportRequired Qualifications:Bachelor's Degree or equivalent work experience2+ years of experience in data analysisProficiency in SQL and MS Office productsExperience with business intelligence toolsSelf-motivat...
Molecular Biologist (Senior)
Freyr is hiring for a leading pharmaceutical client!!.Job Title: Senior Research Scientist - Molecular Biology.Work location: Lab based role at South San Francisco, CA .Education: in biology, chemistry, biochemistry, or molecular biolog....