Sr. Manager, Analytical Development

📋 Description Management of contract drug substance and drug product analytical development and quality control Authoring and review of analytical method transfer and validation protocols and reports Direct batch release support by reviewing and approving sampling plans and analytical data Review stability protocols and monitor various stability programs Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings Partner with QA to manage change controls; lead OOS/OOT and deviation investigations to identify 🎯 Requirements At least 10 years of experience in Analytical Development and/or Quality Control in a Familiarity with CMC analytical regulatory requirements and authoring of IND/IMPD/BLA/NDA/MAA Independently proficient in a variety of analytical techniques in support of biologic and small Ability to communicate effectively with vendors regarding project scope, scientific results and Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices. Subject matter expertise in stability program management, including protocol design, data trending 🎁 Benefits Market-leading compensation 401(k) with employer match Employee Stock Purchase Program (ESPP) Pre-tax commuter benefits (transit and parking) Referral bonus for hired candidates Subsidized lunch and parking on in-office days