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Senior / Executive Director, Analytical Sciences & Quality Control

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Position Summary

This role will lead Analytical Sciences and Quality Control across small molecule and large molecule programs, supporting development from early-stage through commercialization, with a focus on late-stage ADC assets. You will own end-to-end analytical strategies, including product characterization, control strategy, and method lifecycle management, ensuring readiness for global regulatory submissions and commercial supply. You will work closely with internal teams and external partners to drive analytical execution and resolve complex technical challenges. This role includes leadership of a small internal team and cross-functional CMC teams, along with oversight of CDMOs and global partners. This position is expected to operate primarily within East Coast U.S. hours to support frequent interaction with China-based partners.

Key Responsibilities

• Lead Analytical Development (AD) and Quality Control (QC) functions across small molecule and ADC programs.
• Develop and execute analytical strategies in partnership with CDMOs to support candidate selection, clinical development, registration, and commercial supply.
• Serve as technical expert for product characterization, developability, CQA assessment, and analytical troubleshooting.
• Oversee and resolve complex analytical issues, including OOS and OOT investigations.
• Review and approve analytical documentation, including method development, transfer, validation, comparability, and specifications.
• Lead preparation and review of CMC sections for INDs, IMPDs, NDAs, BLAs, MAAs, and other global regulatory submissions.
• Lead cross-functional CMC teams and contribute to integrated development strategy.
• Oversee CDMOs and external partners to drive quality, timelines, and technical alignment.
• Build, lead, and develop a small internal team, including direct management of two team members.

Required Skills and Experience

• Deep expertise in analytical development for biologics, with required experience in large molecules and strong preference for small molecule experience, particularly in integrated pipelines.
• Required experience supporting late-stage ADC development, including characterization, control strategy, and regulatory filings.
• Proven experience required supporting global regulatory submissions for registrational trials and marketing applications (e.g., IND, NDA, BLA, MAA).
• Demonstrated success leading analytical development and managing external CDMOs, including method transfer and validation.
• Strong understanding of cGMP requirements and QC practices, including deviation investigations, CAPA, change control, stability, and validation.
• Demonstrated experience leading cross-functional CMC teams, with accountability for integrated CMC strategy, strongly preferred.
• Prior people management experience preferred.
• Excellent communication, leadership, and decision-making skills.

Education

• PhD in Chemistry, Biochemistry, or related field with 7+ years of relevant biotechnology or pharmaceutical experience.

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