Responsibilities:
- Lead analytical method transfers and method validation activities (protocol design, execution, reporting).
- Author transfer/validation protocols, technical reports, SOPs, and relevant regulatory filing sections.
- Manage analytical method and instrument lifecycle (qualification, maintenance, change control) to support GMP readiness.
- Perform advanced analytical testing for raw materials, in-process, and finished products.
- Provide technical oversight for QC analytical methods/instrumentation; troubleshoot, conduct root-cause analysis, and support deviations and OOS/OOT investigations.
- Design, execute, and oversee stability programs (protocol development, study execution, data review, trend evaluation, technical reporting).
- Support QC systems/documentation/lab practices/analytical controls through ISO 9001 and transition to GMP operations.
Qualifications & Skills:
- Ph.D. in life sciences/chemistry/biochemistry (4+ years relevant industry experience in regulated environment) OR M.S./B.S. (10+ years relevant experience).
- Working knowledge of cGMP and ICH guidelines.
- Proven experience developing analytical method validation strategies and execution.
- Deep technical knowledge/experience with LC-MS, IP-RP-HPLC, and AEX chromatography for oligonucleotide analysis.
- Analytical techniques experience for biological products (ELISA, qPCR, UV-Vis, CE-SDS, HPLC, GC).
Benefits (from job posting):
- Medical, Dental, Vision; Basic Life/AD&D; STD/LTD; 401k match up to 4%; company equity; paid time off (18 holidays); wellness time; annual lifestyle account; ESPP; flexible spending; student debt program; mental health wellness; subsidized lunch; onsite gym; paid parental leave.