Associate Director, Analytical Development

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.