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Associate Director, Analytical Development at Cogent Biosciences - ApplyBlast

Associate Director, Analytical Development

Cogent Biosciences

2 months ago

3.8 on Glassdoor

Remote

Full Time

Director

5 applicants

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About this role

The Associate Director, Analytical Development leads analytical activities across Cogent’s development portfolio and commercial product, partnering with Regulatory CMC, Quality, and external CDMOs to ensure accurate, phase‑appropriate analytical data and documentation. The role provides technical leadership in reviewing, interpreting, and communicating analytical results while supporting regulatory submissions and high‑quality documentation for development and commercialization.

Responsibilities

Lead preparation, review, and approval of analytical documentation
Support analytical method development, validation, transfer, and lifecycle management
Coordinate analytical reporting for drug substance and drug product stability programs

Skills

Qualifications

PhD in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific disciplineMaster's degreeBachelor's degree

About Cogent Biosciences

cogentbio.com

Headquarters

Waltham, Massachusetts, United States

Company Size

51-200 employees

Founded

2014

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Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases, including cancers, autoimmune conditions, and rare diseases. The company leverages validated biology to design best-in-class small molecule therapeutics, with its lead program bezuclastinib targeting conditions such as Systemic Mastocytosis and Gastrointestinal Stromal Tumors (GIST). Cogent operates discovery and development offices in Boulder, Colorado and Waltham, Massachusetts, and is actively advancing clinical-stage programs including a Phase 3 trial and an FDA-accepted NDA for bezuclastinib.