Senior Director, CMC Analytical

Maze Therapeutics•South San Francisco, CA

13d•$257,000 - $314,000•Hybrid

About The Position

Join us at Maze Therapeutics as our Senior Director, CMC Analytical. In this highly visible leadership role within Technical Operations, you will own the analytical strategy for our early‑phase small molecule programs—setting the direction, building fit‑for-phase plans, and ensuring execution with internal and external partners. You’ll lead analytical method development, validation, and transfer; establish product specifications; and oversee QC testing at CMOs and third‑party labs. Reporting to the VP, Technical Operations, you will partner closely across CMC, Quality, and key internal stakeholders to enable program milestones and support regulatory success, ultimately helping bring potential medicines to patients.

Requirements

Advanced degree in Chemistry or related field; a PhD is preferred
12+ years of experience in small molecule analytical work in the pharmaceutical industry
Effectively communicates across all levels and functions, with exceptional verbal and written skills
Thorough understanding of cGMPs, ISO, and ICH guidelines, and industry best practices
Demonstrated leadership abilities honed through previous roles, driving teams toward success
Understanding of Design of Experiments (DOE) and Quality by Design (QbD) principles
Strong collaboration skills and a track record of building effective partnerships (internal and external)
Willingness to travel as needed to support external partners and CMC goals

Nice To Haves

Robust project management skills are a plus

Responsibilities

Develop and execute a forward-thinking analytical strategy aligned to CMC plans, program phase, and company priorities.
Define fit-for-phase specifications for drug substance (DS) and drug product (DP) manufacturing to enable clinical manufacturing and regulatory filings.
Oversee a range of analytical activities at third party labs including structure elucidation, method development and validation, stability studies, method transfer, testing of clinical materials and qualification and maintenance of reference standards.
Own Maze approval of key analytical documents such as methods, validation protocols/reports, stability protocols/reports, specifications, change controls, and deviations/investigations.
Evaluate and select CMOs and analytical vendors by assessing capability, quality systems, and execution track record.
Manage external method development and stability studies and coordinate internal analytical lab work, ensuring alignment with DS/ DP development needs and timelines.
Partner with Quality Assurance (QA) to establish and improve SOPs and analytical workflows that promote efficiency, consistency, and compliance.
Author and review CMC sections of regulatory submissions, ensuring analytical content is accurate, complete, and inspection-ready.
Foster strong communication, decision-making, and alignment across the CMC team and internal stakeholders.