Director, Analytical Development

The Opportunity:

• Provide strategic and organizational leadership for analytical development activities supporting small molecule API and drug product development, including oversight of phase appropriate control strategies, specification setting, analytical lifecycle management, and overall CMC analytical strategy.

• Lead and oversee analytical development execution across internal and external teams to support the development, characterization, and manufacturing of API and drug product, while actively contributing to cross functional PDM project teams.

• Provide strategic guidance and oversight for regulatory submission activities, including authoring and review Quality sections of regulatory submissions, and leading responses to regulatory queries.

• Establish and drive analytical strategies, technology selection, and operational execution through effective management of CDMOs, CROs, and contract laboratories, with accountability for quality, timelines, risk management, and delivery.

• Provide leadership oversight for preparation, review, and approval of analytical protocols, reports, specifications, investigations, and technical documentation to ensure scientific excellence, regulatory compliance, and inspection readiness.

• Build strong cross functional partnerships and influence across Drug Product, Drug Substance, Regulatory Affairs, QA, Project Management, Medicinal Chemistry, DMPK, Toxicology and senior leadership teams to drive strategic decision making and achievement of program and organizational goals.

Required Education, Experience and Skills:

• PhD or Masters in related field.

• 10+ years of progressive leadership experience in analytical development within the pharmaceutical or biotechnology industry.

• Proven ability to lead cross functional teams, influence organizational decision making, and drive execution of complex development strategies in a matrix environment.

• Extensive strategic and operational leadership experience overseeing analytical activities across small molecule drug development, with strong preference for late phase development, regulatory approval, and commercialization readiness.

• Excellent communication, collaboration, people leadership, and stakeholder management skills.

• Deep understanding of CMC strategies and analytical enablement for small molecule development programs.

• Demonstrated leadership experience managing external partners, including CROs and CDMOs, to ensure high quality deliverables and program execution.

• Strong knowledge of global regulatory requirements and experience supporting regulatory submissions, including INDs, IMPDs, NDAs, and/or MAAs.

• In-depth understanding of ICH guidelines, GMP regulations, and current industry best practices related to analytical development and quality.

• Strong strategic thinking and innovation mindset with the ability to independently evaluate complex issues, identify risks, and implement effective solutions.

• Ability to prioritize and lead multiple initiatives in a fast paced, dynamic, and highly collaborative environment.

 Preferred Skills:

• PhD preferred (minimum MS) in Analytical Chemistry, Organic Chemistry, or a related scientific discipline. #LI-Hybrid #LI-CT1