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