Remote: Associate Director, Analytical Development

Cogent Biosciences, Inc.; Northern (KY); Hybrid; USD 185,000 - 215,000; Full time

Benefits offered by this job

Bonus

Stock awards

Premium family medical/dental/vision

Job summary

Cogent Biosciences is seeking an Associate Director, Analytical Development for remote work in the United States. You will lead analytical activities across Cogent’s development portfolio, partnering with Regulatory CMC, Quality, and external CDMOs to ensure analytical data, methods, specifications, and regulatory documentation are accurate and aligned with program objectives.

The role provides technical leadership in reviewing and interpreting analytical results while supporting method

Qualifications

• PhD in Chemistry, Pharmaceutical Sciences, Chemical Engineering or related field with 8+ years of industry experience, OR Master's with 10+ years, OR Bachelor's with 12+ years.
• Experience in analytical development, analytical reporting, CMC writing, or related pharmaceutical development functions.
• Strong understanding of small molecule analytics, method validation, transfer, stability testing, specifications, and control strategies.
• Experience authoring, reviewing, and approving analytical methods, protocols, reports, and regulatory documentation.
• Experience reviewing analytical data from CDMOs, CROs, and external testing laboratories.

Responsibilities

• Lead preparation, review, and approval of analytical reports, data summaries, protocols, methods, and other CMC documentation.
• Review data packages supporting release testing, stability studies, and drug substance/intermediates.
• Collaborate with Regulatory CMC, Quality, and external CDMOs for timely documentation delivery.
• Support method development, validation, transfer, and lifecycle management across programs.
• Coordinate reporting for stability programs and ensure accurate documentation and communication.
• Assist in preparing CMC sections for regulatory submissions and responses.
• Participate in investigations related to deviations, OOS, OOT, and laboratory events.
• Engage with external labs to ensure compliant, timely analytical deliverables.
• Drive continuous improvement in reporting processes and data integrity.

Skills

Analytical development

CMC writing

Regulatory knowledge

HPLC/UPLC

Data interpretation

Education

PhD in Chemistry or related field

Job description

Cogent Biosciences is seeking an Associate Director, Analytical Development for remote work in the United States. You will lead analytical activities across Cogent’s development portfolio, partnering with Regulatory CMC, Quality, and external CDMOs to ensure analytical data, methods, specifications, and regulatory documentation are accurate and aligned with program objectives.

The role provides technical leadership in reviewing and interpreting analytical results while supporting method