Associate Director, Analytical Development

About this role

<p><strong>Who We Are:</strong></p> <p><span class="TextRun SCXW220448737 BCX0" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW220448737 BCX0" data-ccp-parastyle="No Spacing">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.</span></span><span class="EOP SCXW220448737 BCX0" data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <hr> <p><strong>The Role: </strong></p> <p>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.</p> <hr> <p><strong>Responsibilities:</strong></p> <div> <ul> <li>Lead the preparation, review, and approval of analytical reports, data summaries, protocols, specifications, methods, and other CMC technical documentation.</li> <li>Review analytical data packages supporting release testing, stability studies, drug substance, intermediates, and drug product manufacturing activities.</li> <li>Partner closely with Regulatory CMC, Quality, and external CDMOs to ensure timely delivery of analytical documentation and reports.</li> <li>Support analytical method development, validation, qualification, transfer, and lifecycle management activities across development and commercial programs.</li> <li>Author, review, and manage technical documents including analytical methods, validation protocols and reports, specifications, trend reports, and regulatory submission documentation.</li> <li>Coordinate analytical reporting activities for drug substance and drug product stability programs and ensure data are accurately documented and communicated.</li> <li>Support the preparation and review of CMC sections for regulatory submissions, responses to health authorities, and other regulatory filings.</li> <li>Participate in analytical investigations related to deviations, OOS, OOT, and laboratory events, ensuring documentation meets quality and regulatory expectations.</li> <li>Collaborate with external laboratories and CDMOs to ensure analytical deliverables are scientifically sound, compliant, and aligned with program timelines.</li> <li>Drive continuous improvement initiatives focused on analytical reporting processes, data integrity, document quality, and operational efficiency.</li> </ul> <hr> <p><strong>Qualifications:</strong></p> <ul> <li> <ul> <li>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.</li> <li>Experience in analytical development, analytical reporting, CMC technical writing, or related pharmaceutical development functions.</li> <li>Strong understanding of small molecule analytical development, method validation, method transfer, stability testing, specifications, and control strategies.</li> <li>Demonstrated experience authoring, reviewing, and approving technical documents including analytical methods, protocols, reports, and regulatory-supporting documentation.</li> <li>Experience reviewing analytical data generated by CDMOs, CROs, and external testing laboratories.</li> <li>Working knowledge of analytical techniques such as HPLC/UPLC, GC, dissolution, spectroscopy, mass spectrometry, wet chemistry, particle size analysis, and related pharmaceutical characterization methods.</li> <li>Familiarity with ICH, FDA, EMA, and other global regulatory requirements related to analytical development and CMC documentation.</li> <li>Strong scientific writing, data interpretation, problem-solving, and project management skills.</li> <li>Excellent verbal and written communication skills with the ability to effectively communicate complex technical information to diverse audiences.</li> <li>Proven ability to work effectively within a cross-functional matrix organization and build strong relationships with internal stakeholders and external partners.</li> <li>Highly organized with the ability to manage multiple priorities in a fast-paced biotech…