Executive Director, Analytical Chemistry Lead
Core
Owns analytical development strategy and execution oversight to ensure fit-for-purpose methods and characterization packages support DS/DP decisions, release readiness, and stability programs.
Role type
Executive Director, Analytical Chemistry Lead
Builds
Analytical methods, characterization packages, and control strategies for biopharmaceutical therapeutics
Domain
Biopharmaceuticals / Analytical Chemistry
Required skills
Analytical method lifecycle management, Data integrity standards, External lab governance, Cross-functional strategy alignment, Regulatory filing support, Vendor oversight
Preferred skills
Solid-state characterization, Polymorph programs, Pharmaceutical regulatory filings, HA responses
Technologies
N/A
Responsibilities
Define analytical strategy and prioritization across assets, Ensure method development/qualification plans meet program timelines, Govern external analytical execution and data review standards, Align specs and reference standards with DS/DP strategy, Ensure analytical rationales are ready for CMC authoring and filings
Seniority
Executive Director, Strategic Leadership
