Senior Scientist I Analytical Development

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 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
• Absorb and assist in preparation of CMC documents for regulatory submissions (IND, IMPD, and/or NDA)

The Ideal Candidate

• 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
• Experience and knowledge in ICH, cGMP and regulatory requirements

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.

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!