Analytical Development, Senior Manager

Job description

Job responsibilities

• Provide technical oversight of external analytical resources at CDMOs, acting as the primary point of contact for troubleshooting and deviation resolution.
• Manage the transfer, optimization, and validation of analytical methods for both DS and DP, ensuring compliance with ICH guidelines and GMP requirements.
• Review and approve CDMO protocols, reports, and raw data for method validation, stability studies, and release testing.
• Assess and mitigate technical risks related to analytical control strategies, degradation pathways, and impurity profiling (including genotoxic impurities).
• Review and interpret analytical data, ensuring data integrity, traceability, and regulatory compliance.
• Participate in risk assessments related to analytical control and product quality.
• Lead the design and execution of late-stage method validation strategies (Phase 3/PPQ readiness) to ensure methods are commercially viable and robust.
• Oversee forced degradation studies and stability-indicating method development for complex small molecule formulations.

Job requirements

• Ph.D. in Analytical Chemistry or related field with 10+ years of industry experience (or M.S. with 15+ years).
• Extensive experience with Small Molecule therapeutics in both Drug Substance and Drug Product is mandatory
• 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 timelines and quality standards.
• Experience overseeing analytical work at CDMOs/CROs, including protocol and report review, data trending, and deviation management.
• Solid understanding of GMP principles, data integrity standards, and regulatory expectations for analytical control strategies.
• Hands-on experience authoring and reviewing Module 3 (Quality) sections for NDAs/MAAs.