Senior Scientist, Analytical Development and Quality Control - Drug Product
Core
Lead analytical method development, validation, and lifecycle management for drug product formulations (including amorphous solid dispersions and lipid-based systems) to support oncology and inflammation & immunology programs.
Role type
Senior Scientist, Analytical Development and Quality Control (Drug Product)
Builds
Drug product analytical methods, control strategies, and regulatory documentation for late-phase development and commercialization.
Domain
Biopharmaceuticals / Oncology & Immunology / Analytical Chemistry
Required skills
Chromatographic method development, Dissolution method development, Stability study design, Validation strategy, Regulatory submission authoring, CDMO oversight, Root cause analysis, Statistical trend analysis, cGMP compliance, Technical writing
Preferred skills
Experience with amorphous solid dispersions (ASDs), Experience with lipid-based formulations, Experience with contract testing laboratories (CTLs), Global regulatory filing experience
Technologies
HPLC, UPLC, DSC, DTA, FTIR, NMR, UV-Vis, Mass Spectrometry, Stability chambers, LIMS
Responsibilities
Lead analytical method development validation and lifecycle management for drug product formulations; Support PPQ activities, commercialization, and lifecycle management for drug product analytical methods; Design and oversee DP development, registration batch, and commercial stability programs; Author and review DP analytical development reports to support regulatory submissions; Oversee and support analytical activities at CDMOs and contract testing laboratories; Contribute to investigations (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 specifications, validation and stability protocols/reports, and certificates of analysis; Author and review analytical sections of regulatory submissions (IND/IMPD/NDA); Collaboratively author responses to health authority requests for information; Maintain and organize analytical documentation and data to ensure traceability, data integrity, and inspection readiness; Follow cGMP requirements and internal SOPs.
Seniority
Senior, hands-on IC
