Analytical Development, Senior Manager

📋 Description

• Provide technical oversight of external analytical resources at CDMOs, acting as the primary point
• Manage the transfer, optimization, and validation of analytical methods for both DS and DP
• Review and approve CDMO protocols, reports, and raw data for method validation, stability studies
• Assess and mitigate technical risks related to analytical control strategies, degradation pathways
• Review and interpret analytical data, ensuring data integrity, traceability, and regulatory
• Participate in risk assessments related to analytical control and product quality.

🎯 Requirements

• Ph.D. in Analytical Chemistry or related field with 10+ years of industry experience (or M.S. with
• Extensive experience with Small Molecule therapeutics in both Drug Substance and Drug Product is
• Proven track record in late-stage development, specifically Phase 3 to Commercial launch.
• Expert knowledge of ICH guidelines (Q1, Q2, Q3, Q6, Q7, Q14) and cGMP requirements.
• Demonstrated experience managing external partners (CROs/CMOs) and holding them accountable to
• Experience overseeing analytical work at CDMOs/CROs, including protocol and report review, data