Senior Scientist I Analytical Development
Alumis · South San Francisco, CA · Yesterday
On-siteAnalyst$112k/yrFull-time
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 techniques for 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
- Absorb and assist in the 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)
Requirements
- BS/MS in chemistry or pharmaceutical sciences with 5+ years of experience in analytical 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
Qualifications
- Thorough understanding of the associated quality and regulatory awareness
Skills
- Strong analytical skills
- Excellent problem-solving abilities
- Effective communication and collaboration skills
Benefits
- 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
Pay
The salary range for this position is $112,000 USD to $135,000 USD annually.
Schedule
This position is located in South San Francisco, CA. At this time, we are not considering fully remote applicants.