Responsibilities
- Support development, validation, and transfer of analytical methods to support starting material, intermediate, drug substance and drug product testing at CMOs/CTLs
- Execute and/or support the in-house method development activities using UPLC/HPLC, LC-MS, KF, and dissolution instrumentation and techniquesfor Phase 1 to late-stage drug development
- Review CMO/CTL analytical data (in-process, release, and stability data), protocols and reports
- Trend stability and release data using statistical methods
- Assist in investigation for various non-conformance events at CMOs/CTLs
- Collaborate with CMC team, QA and CMOs/CTLs towards timely generation and approval of documents
- Communicate scientific results (oral and written) in a clear and concise manner within cross-functional teams
- Author technical reports and documents in support of regulatory filing
- Assist in preparation of CMC documents for regulatory submissions (IND, IMPD, and/or NDA)
The Ideal Candidate
- BS/MSinchemistryor pharmaceutical sciences with5+yearsofexperienceinanalytical development
- Experience with analytical techniques for small drug molecules and oral solid formulations required, including UPLC/HPLC, LC-MS, KF, dissolution testing, IR, particle size analysis, and solid-state characterization techniques
- Proven track record in applying analytical techniques to solve challenging problems
- Experience in working with CMOs and CTLs
- Experience in early to late-stage drug development
- Strong organizational and communication skills
- Comfortable in a fast-paced small company environment and a strong team player
- Experience and knowledge in ICH, cGMP and regulatory requirements
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 $112,000 USD to $135,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.
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.
Alumis Inc. is an equal opportunity employer.
