Senior Scientist, Analytical Development and Quality Control - Early Phase

Responsibilities:
- Lead DP analytical method development, validation, and lifecycle management for ASDs and lipid-based formulations.
- Support PPQ, commercialization, commercial QC, and lifecycle management for analytical methods and control strategies.
- Design/oversee DP development, registration batch, and commercial stability programs (protocols, trend analysis).
- Author/review DP analytical development reports to support IND/IMPD/NDA submissions and marketing authorization.
- Oversee analytical activities (method development, validation, QC testing) at CDMOs and CTLs.
- Contribute to investigations (OOS/OOE/OOT), root cause analysis, and CAPAs.
- Critically review analytical data, protocols, reports, specifications, and documentation.
- Trend stability data; support retest periods and shelf-life using statistical methods.
- Collaborate on material control strategies and specifications.
- Author technical documentation (validation/stability protocols/reports, specifications, COAs, storage statements) and health authority responses.
- Maintain analytical documentation for traceability, data integrity, and inspection readiness; follow cGMP/SOPs. Travel up to 5% as required.

Qualifications:
- Advanced degree in Chemistry, Pharmaceutics, or related field.
- Senior Scientist: BS/MS with 14+ years or PhD with 8+ years industrial CMC experience.
- Strong DP analytical development/validation experience; expertise with ASDs and/or lipid-based formulations.
- CDMO/contract testing lab oversight experience.
- Experience supporting regulatory submissions (IND/IMPD/NDA) and global filings.
- ICH, cGMP, and pharmacopeial chapter fluency; cross-functional collaboration.
- Strong technical writing and ability to manage multiple priorities.

Salary Range: $162K–$186K