Associate Director, Analytical Development (Remote)

Cogent Biosciences, Inc.; United States; Remote; USD 185,000 - 215,000; Full time

Benefits offered by this job

Competitive salary

Stock awards

Medical, dental, and vision premiums

401(k) match

Paid time off

Parental leave

Paid family leave

Short-term disability

Job summary

Cogent Biosciences, Inc. is seeking an Associate Director of Analytical Development to lead analytical activities across its development portfolio and commercial product.

You will partner with Regulatory CMC, Quality, and CDMOs to ensure accurate data, methods, specifications, and regulatory-supporting documentation for submissions. The role requires deep expertise in small molecule analytical development, method validation, and lifecycle management, with a track record of high-quality

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 technical writing, or related pharmaceutical development functions.
• Strong understanding of small molecule analytical development, method validation, method transfer, stability testing, specifications, and control strategies.
• Demonstrated experience authoring, reviewing, and approving technical documents including analytical methods, protocols, reports, and regulatory-supporting documentation.
• Experience reviewing analytical data generated by CDMOs, CROs, and external testing laboratories.
• Strong scientific writing, data interpretation, problem-solving, and project management skills.

Responsibilities

• Lead the preparation, review, and approval of analytical reports, data summaries, protocols, specifications, methods, and other CMC technical documentation.
• Review analytical data packages supporting release testing, stability studies, drug substance, intermediates, and drug product manufacturing activities.
• Partner with Regulatory CMC, Quality, and external CDMOs to ensure timely delivery of analytical documentation and reports.
• Support analytical method development, validation, qualification, transfer, and lifecycle management across development and commercial programs.
• Author, review, and manage technical documents including analytical methods, validation protocols and reports, specifications, trend reports, and regulatory submission documentation.
• Coordinate analytical reporting activities for drug substance and drug product stability programs and ensure data are accurately documented and communicated.
• Support the preparation and review of CMC sections for regulatory submissions, responses to health authorities, and other regulatory filings.
• Participate in analytical investigations related to deviations, OOS, OOT, and laboratory events, ensuring documentation meets quality and regulatory expectations.
• Collaborate with external laboratories and CDMOs to ensure analytical deliverables are scientifically sound, compliant, and aligned with program timelines.
• Drive continuous improvement initiatives focused on analytical reporting processes, data integrity, document quality, and operational efficiency.

Skills

Analytical development

Analytical reporting

Regulatory writing

Data interpretation

Project management

Scientific writing

Cross-functional collaboration

Verbal and written communication

Education

PhD in Chemistry/Pharmaceutical Sciences/ Chemical Engineering

MS in related field

BS in related field

Tools

HPLC/UPLC

GC

Dissolution

Mass spectrometry

Spectroscopy

Wet chemistry

Particle size analysis

Job description

Cogent Biosciences, Inc. is seeking an Associate Director of Analytical Development to lead analytical activities across its development portfolio and commercial product.

You will partner with Regulatory CMC, Quality, and CDMOs to ensure accurate data, methods, specifications, and regulatory-supporting documentation for submissions. The role requires deep expertise in small molecule analytical development, method validation, and lifecycle management, with a track record of high-quality