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Senior Scientist, Analytical Development
Seranbio
Bend, USA
Full-time
Senior · 8+ years experience
Onsite
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- Independently develop and optimize analytical methods for drug products across early- and late-stage clinical development through commercial manufacturing.
- Provide strategic guidance for method validation and transfer activities and design comprehensive validation and transfer plans.
- Initiate and perform analytical testing such as GC, UHPLC/HPLC, Water Content, Water Activity, Dissolution to support small molecules drug product development in GMP environment
- Lead technical support efforts for QC laboratories, driving OOS/OOT investigations, corrective actions, and analytical method lifecycle management.
- Plan, troubleshoot, and independently execute laboratory studies, generating high‑quality data for CMC decision‑making.
- Prepare and review technical reports, analytical methods, and protocols, contributing to regulatory‑ready documentation.
- Collaborate with cross‑functional teams (QC, QA, Process Development, Project Management) and communicate results to internal and external stakeholders.
- Act as a subject matter expert (SME) in analytical development, providing technical leadership and supporting analytical strategy.
- Initiate, draft, and perform testing for discrepancy reports; as necessary.
- Maintain GMP training certification to be able to perform work in a GMP laboratory
- Provide regular updates to management on projects
- Identify opportunities for process improvements and propose solutions
- Identifies out of trend data.
- Responsibilities may increase in scope to align with company initiatives.
- Proven analytical method development experience (preferably HPLC and GC) with at least 8-10 years in a cGMP pharmaceutical industry lab
- Scientific curiosity and willingness to learn
- Demonstrates intermediate expertise with analytical equipment (e.g. disso, KF, GC, LC, XRPD, or mDSC; preferred LC and GC)
- Conveys general understanding of USP, ICH, and EP guidance as they pertain to method validation/qualification/transfer and general chapters for relevant instrumentation
- Excellent verbal and written communication skills
- Excellent organizational skills and attention to detail
- Excellent time management skills with a proven ability to meet deadlines
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