Analytical Development, Senior Manager
Core
Senior Manager leading analytical chemistry for small molecule drug development, managing CDMO partnerships, method validation, and regulatory CMC documentation.
Role type
Senior Manager, Analytical Development (Small Molecule)
Builds
Robust analytical methods and CMC documentation for late-stage small molecule therapeutics (Phase 3 to Commercialization)
Domain
Pharmaceutical / Analytical Chemistry / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development and validation, CMC documentation, CDMO management, ICH guidelines expertise, GMP compliance, Risk assessment, Technical writing, Data integrity, Stability study design, Impurity profiling
Preferred skills
Experience with genotoxic impurities, Quality by Design (QbD) principles, Cross-functional team leadership
Technologies
ICH Q1, Q2, Q3, Q6, Q7, Q14, GMP
Responsibilities
Provide technical oversight of external analytical resources at CDMOs; Manage transfer, optimization, and validation of analytical methods for DS and DP; Review and approve CDMO protocols, reports, and raw data; Assess and mitigate technical risks related to analytical control strategies; Lead design and execution of late-stage method validation strategies; Oversee forced degradation studies and stability-indicating method development; Draft, review, and edit analytical CMC sections (Module 3) for regulatory submissions; Author responses to Information Requests (IRs) from health authorities.
Seniority
Senior Manager, hands-on IC with strategic oversight
