Senior Scientist, Analytical Development and Quality Control

About the role

The Senior Scientist will lead analytical method development, validation, and lifecycle management for drug product formulations, including amorphous solid dispersions (ASDs) and lipid-based systems. They will support PPQ activities, commercialization, commercial QC, and lifecycle management for drug product analytical methods and control strategies. This role will also contribute to analytical development for new drug products and dosage forms, working closely with cross-functional teams to ensure alignment and integration of analytical and QC strategies across development stages.

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
• Perform critical review of analytical data, protocols, reports, specifications, and related documentation
• Trend stability data and support establishment of retest periods and shelf life using statistical methods
• Collaborate in 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
• Act as a key contributor to multidisciplinary teams, including Chemical Development, Pharmaceutical Development, Regulatory, Quality, Preclinical, Supply Chain, Medicinal Chemistry, and DMPK
• Maintain and organize analytical documentation and data to ensure traceability, data integrity, and inspection readiness
• Follow cGMP requirements and internal SOPs
• Travel up to 5%, as required

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)
• Able to manage multiple priorities in a fast-paced environment
• Excellent communication and cross-functional collaboration skills