Responsibilities:
- Support development, validation, and transfer of analytical methods for starting material, intermediate, drug substance, and drug product testing at CMOs/CTLs.
- Execute/support in-house method development using UPLC/HPLC, LC-MS, KF, and dissolution instrumentation/techniques for Phase 1 to late-stage development.
- Review CMO/CTL analytical data (in-process, release, and stability), protocols, and reports.
- Trend stability and release data using statistical methods.
- Assist with investigations for non-conformance events at CMOs/CTLs.
- Collaborate with CMC, QA, and CMOs/CTLs to generate and approve documents timely.
- Communicate results (oral and written) clearly within cross-functional teams.
- Author technical reports and regulatory filing documents.
- Assist in preparation of CMC documents for IND, IMPD, and/or NDA.
Qualifications:
- BS/MS in chemistry or pharmaceutical sciences with 5+ years of analytical development experience.
- Experience with small drug molecule and oral solid formulation analytical techniques: UPLC/HPLC, LC-MS, KF, dissolution testing, IR, particle size analysis, and solid-state characterization.
- Proven ability to apply analytical techniques to solve challenging problems.
- Experience working with CMOs/CTLs.
- Experience in early to late-stage drug development.
- Strong organizational and communication skills; comfortable in a fast-paced small company; team player.
- Knowledge of ICH, cGMP, and regulatory requirements.
Benefits:
- Health insurance premiums paid at 90% for employee, 80% for dependents.
- $100 monthly cell phone stipend.
- Unlimited PTO for Exempt employees.
- Free onsite gym and kitchen with snacks/drinks.