Associate Director, Analytical Development

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

Who We Are

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. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing.

The Role

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.

Our Locations

Waltham, MA: Our headquarters is located in the Greater Boston life sciences community, with an open, collaborative office environment designed to support teamwork and connection. Employees benefit from convenient on-site amenities, including free on-site parking and gym facilities in the building.

Boulder, CO: Our Boulder location is home to Cogent’s discovery research organization and a key scientific hub with strong leadership based on site. Situated in the greater Denver-Boulder