[Hiring] Associate Director, Analytical Development @Cogent Biosciences

Role Description

The Associate Director, Analytical Development, is responsible for leading analytical activities across Cogent’s development portfolio and commercial product. This role within CMC will partner closely with Regulatory CMC, Quality, and external CDMOs to ensure analytical data, reports, methods, specifications, and regulatory-supporting documentation are accurate, phase-appropriate, and aligned with program objectives. The successful candidate will provide technical leadership in the review, interpretation, and communication of analytical results while ensuring high-quality documentation supports development, commercialization, and global regulatory submissions.

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 closely 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 activities 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.

Qualifications

• PhD in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline with 8+ years of relevant industry experience, OR Master's degree with 10+ years of experience, OR Bachelor's degree with 12+ years of experience.
• 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.
• Working knowledge of analytical techniques such as HPLC/UPLC, GC, dissolution, spectroscopy, mass spectrometry, wet chemistry, particle size analysis, and related pharmaceutical characterization methods.
• Familiarity with ICH, FDA, EMA, and other global regulatory requirements related to analytical development and CMC documentation.
• Strong scientific writing, data interpretation, problem-solving, and project management skills.
• Excellent verbal and written communication skills with the ability to effectively communicate complex technical information to diverse audiences.
• Proven ability to work effectively within a cross-functional matrix organization and build strong relationships with internal stakeholders and external partners.
• Highly organized with the ability to manage multiple priorities in a fast-paced biotech environment.

Preferred Qualifications

• Experience supporting late-stage development or commercial programs.
• Experience contributing to IND, NDA, MAA, or other global regulatory submissions.

Salary Range

• $185,000 - 215,000 USD
• Target Bonus: 20%
• Exact compensation will vary based on skills, experience, and location.

Benefits

• 100% coverage of medical, dental, and vision premiums for you and your family.
• Funding up to 75% of in-network deductibles.
• 401(k) match with immediate vesting.
• Generous paid time off.
• 12 weeks of fully paid parental leave.
• Paid family and medical leave for all employees regardless of location.
• Company-paid short-term disability coverage for up to 20 weeks.
• Wellness programs, tuition reimbursement, and inclusive family-forming support.

Company Description

Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V.