Senior Scientist, Analytical Development and Quality Control
BioSpace · Brisbane, CA · Today
Analyst$161k/yrFull-time
Key Responsibilities
- Lead analytical method development, validation, and lifecycle management for drug product formulations, including amorphous solid dispersions (ASDs) and lipid-based systems
- Support PPQ activities, commercialization, commercial QC, and lifecycle management for drug product analytical methods and control strategies
- Design and oversee DP development, registration batch, and commercial stability programs, including protocol development and trend analysis
- Author and review DP analytical development reports to support regulatory submissions, and marketing authorization
- Oversee and support analytical activities, including method development, validation, and QC testing conducted at CDMOs and contract testing laboratories (CTLs)
- Contribute to investigations (e.g., OOS, OOE, OOT), root cause analysis, and CAPAs
- Trend stability data and support establishment of retest periods and shelf life using statistical methods
- Contribute to the development and justification of material control strategies and specifications
- Author technical documents, including analytical development reports, specifications, validation and stability protocols/reports, certificates of analysis (COAs), and storage statements
- Author and review analytical sections of regulatory submissions (e.g., IND/IMPD/NDA)
- Collaboratively author responses to health authority requests for information
Qualifications
- Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field)
- Senior Scientist: BS/MS degree with 14+ years or PhD with 8+ years of industrial CMC experience
- Strong experience in drug product analytical development and validation
- Experience with analytical development for amorphous solid dispersions (ASDs) and/or lipid-based formulations
- Experience in CDMO and contract testing lab oversight
- Experience supporting regulatory submissions (e.g., IND, IMPD, NDA) and global regulatory filings
- Fluency with ICH guidelines, cGMPs, and pharmacopeial chapters
- Ability to work effectively in a cross-functional environment
- Strong technical writing skills (e.g., development reports, regulatory documents)
- Ability to manage multiple priorities in a fast-paced environment
- Excellent communication and cross-functional collaboration skills