Analytical Development Director, CMC Strategy & Submissions

Cogent Biosciences; Waltham (MA); On-site; USD 180,000 - 210,000; Full time

Benefits offered by this job

Stock awards

Paid parental leave

Excellent health benefits

Job summary

Cogent Biosciences is seeking an Associate Director of Analytical Development to lead analytical activities across development and commercial programs. This role partners with Regulatory CMC, Quality, and external CDMOs to ensure robust data, methods, and regulatory documents are accurate and aligned with program objectives.

The candidate will provide technical leadership in interpreting results and ensuring high-quality documentation supports development, commercialization, and global

Qualifications

• PhD or relevant master's with extensive industry experience.
• Experience in analytical development, reporting, and CMC documentation.
• Familiarity with regulatory expectations (ICH, FDA, EMA).
• Experience reviewing data generated by CDMOs/CROs.

Responsibilities

• Lead preparation, review, and approval of analytical reports, summaries, protocols, and methods.
• Review data packages for release testing, stability studies, and drug product manufacturing.
• Collaborate with Regulatory CMC, Quality, and external CDMOs for timely analytical documentation.
• Support method development, validation, transfer, and lifecycle management across programs.
• Author and manage technical documents including validation protocols and regulatory submissions.
• Coordinate analytical reporting for stability programs and ensure accurate documentation.

Skills

Analytical development

CMC writing

Regulatory collaboration

Cross-functional leadership

Data interpretation

Project management

Education

PhD in Chemistry/Pharmaceutical Sciences/Chemical Engineering

MS with 10+ years experience

BS with 12+ years experience

Tools

HPLC/UPLC

GC

Mass spectrometry

Job description

Cogent Biosciences is seeking an Associate Director of Analytical Development to lead analytical activities across development and commercial programs. This role partners with Regulatory CMC, Quality, and external CDMOs to ensure robust data, methods, and regulatory documents are accurate and aligned with program objectives.

The candidate will provide technical leadership in interpreting results and ensuring high-quality documentation supports development, commercialization, and global