Director, Analytical Development

Responsibilites:
Management of contract analytical development activities and timelines
Review analytical method transfer documentation and release/stability data for drug substance and drug product
Author, review, and approve analytical technical reports
Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings.
Participate in the CMC strategic planning
Education, Experience & Skills Requirements:
Ph. D./M.S. in life sciences, ideally Chemistry, Pharmacological Chemistry preferred. B.S. will be considered with additional 5 years of industrial experience
10+ years' experience in analytical development in a pharmaceutical setting
Expertise and/or familiarity with the current analytical techniques for pharmaceutical development
Knowledge and direct experience with CMC analytical requirements for IND/IMPD and NDA/MAA filing
Ability to communicate effectively with vendors and external partners regarding project scope, scientific results, and project updates
Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices
Knowledge of CMC analytical requirements and author experiences with NDA/MAA filing
Strong oral and written communication skills
Proven abilities in leadership and personnel management
Ability to accommodate as much as 25% travel