Lead, Analytical Development & CMC Strategy

Cogent Biosciences, Inc.; Waltham (MA); On-site; USD 185,000 - 215,000; Full time

Job summary

Cogent Biosciences, Inc. seeks an Associate Director of Analytical Development to lead analytical activities across the development portfolio.

You will collaborate with Regulatory CMC, Quality, and external CDMOs to ensure accurate data, methods, and regulatory-supporting documentation aligned with program objectives. The role requires technical leadership in reviewing analytical results, high-quality documentation for development, commercialization, and global regulatory submissions, and strong

Qualifications

• PhD or MS with extensive experience in analytical development and CMC writing.
• Experience leading analytical data packages and regulatory documentation.
• Strong understanding of small molecule characterization and method validation.
• Experience reviewing data generated by CDMOs, CROs, and external labs.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Lead preparation, review, and approval of analytical reports and regulatory docs.
• Review data packages supporting release testing and stability studies.
• Collaborate with Regulatory CMC, Quality, and CDMOs for timely deliverables.
• Support method development, validation, transfer, and lifecycle management.
• Author and manage analytical methods, validation reports, and trend analyses.
• Coordinate stability programs and ensure accurate documentation.
• Prepare CMC sections for regulatory submissions and responses.
• Investigate deviations, OOS/OOT events with compliant documentation.
• Coordinate with external labs to ensure sound, compliant deliverables.
• Drive continuous improvement of analytical reporting and data integrity.

Skills

Analytical development

CMC writing

Regulatory submissions

Cross-functional collaboration

Data interpretation

Education

PhD in Chemistry or related

MS in Pharmaceutical Sciences

BS in Chemistry

Tools

HPLC/UPLC

Mass spectrometry

GC

Job description

Cogent Biosciences, Inc. seeks an Associate Director of Analytical Development to lead analytical activities across the development portfolio.

You will collaborate with Regulatory CMC, Quality, and external CDMOs to ensure accurate data, methods, and regulatory-supporting documentation aligned with program objectives. The role requires technical leadership in reviewing analytical results, high-quality documentation for development, commercialization, and global regulatory submissions, and strong