Senior Manager, Analytical Development CMC

Senior Manager, Analytical Development

We are working with an expanding biopharmaceutical company building out its late-stage small molecule pipeline as it advances toward regulatory filing and commercialization. They are looking to bring in an experienced analytical leader to guide and deliver critical activities.

This position plays a central role within the CMC organization, acting as the technical point of contact for external partners while also supporting internal strategy and execution. You will be responsible for ensuring analytical approaches are fit-for-purpose, compliant, and aligned with late-stage and commercial expectations, while remaining closely involved in day-to-day delivery.

This is a hands-on opportunity suited to someone who enjoys working at both a strategic and execution level within a lean, fast-moving environment.

Key Responsibilities

• Serve as the primary analytical contact for external development and manufacturing partners, providing direction and resolving technical challenges as they arise
• Oversee analytical activities across late-stage programs, including method transfer, refinement, and validation for DS and DP
• Evaluate and approve partner-generated documentation, including validation protocols, reports, and supporting datasets for release and stability testing
• Lead analytical readiness for Phase 3 and commercial manufacturing, ensuring methods are robust, reproducible, and inspection-ready
• Guide stability programs and degradation studies to support product understanding and lifecycle management
• Contribute to the development of control strategies, including impurity assessments and specification setting aligned with regulatory guidance
• Review and interpret analytical results, ensuring consistency, traceability, and adherence to quality standards
• Support risk identification and mitigation related to analytical performance and product quality
• Prepare and review analytical content for regulatory submissions (e.g., IND, NDA, MAA), ensuring clarity and compliance
• Contribute to responses to regulatory agencies on analytical topics
• Work closely with cross-functional teams including Process Development, Formulation, Quality, and Regulatory to ensure aligned program execution

Requirements

• Degree (PhD preferred) in a relevant field.
• Strong expertise in small molecule analytical development
• Experience supporting programs through late-stage development and into submission/approval
• Solid understanding of global regulatory expectations and ICH guidelines related to analytical development
• Demonstrated experience overseeing external partners (CDMOs/CROs), ensuring delivery against timelines and quality expectations
• Hands-on experience with method validation, stability studies, and analytical lifecycle management
• Experience contributing to or authoring regulatory CMC documentation (Module 3)
• Strong understanding of GMP and data integrity requirements
• Effective communicator, able to translate complex technical information across functions
• Comfortable working in a dynamic, execution-focused environment with evolving priorities

Apply today to learn more or reach out directly to [email protected]