Associate Director, Analytical Development

Job not on LinkedIn

🕒 July 30

🇺🇸 United States – Remote

💵 $185k - $215k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 45%

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Cogent Biosciences

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2015

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. With a commitment to advancing best-in-class small molecule therapeutics, Cogent aims to tackle diseases with clear genetic mutations as their cause. Their work is driven by a dedication to improve human health by designing rational precision therapies that address critical unmet medical needs. The company operates with a focus on diseases such as systemic mastocytosis, for which they are currently developing and advancing therapeutics like bezuclastinib. Cogent Biosciences highlights their commitment to transforming patient lives through innovative scientific approaches and robust clinical trials.

📋 Description

• Lead analytical activities across Cogent’s development portfolio and commercial product • Lead 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 • Partner with Regulatory CMC, Quality, and external CDMOs to ensure timely analytical documentation and reports • Support analytical method development, validation, qualification, transfer, and lifecycle management • Author, review, and manage analytical methods, validation protocols and reports, specifications, trend reports, and regulatory submission documentation • Coordinate analytical reporting for drug substance and drug product stability programs • Support CMC sections for regulatory submissions, health-authority responses, and other regulatory filings • Participate in investigations related to deviations, OOS, OOT, and laboratory events • Collaborate with external laboratories and CDMOs to ensure scientifically sound, compliant analytical deliverables • Drive continuous improvement in analytical reporting processes, data integrity, document quality, and operational efficiency

🎯 Requirements

• 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 analytical methods, protocols, reports, and regulatory-supporting documentation • Experience reviewing analytical data generated by CDMOs, CROs, and external testing laboratories • Working knowledge of 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 • Ability to work effectively within a cross-functional matrix organization and build relationships with internal stakeholders and external partners • Highly organized with the ability to manage multiple priorities in a fast-paced biotech environment • Preferred: experience supporting late-stage development or commercial programs • Preferred: experience contributing to IND, NDA, MAA, or other global regulatory submissions

🏖️ Benefits

• Competitive salary • Target bonus of 20% • Ongoing stock awards • 100% employer-paid medical, dental, and vision premiums for employees and families • Employer funding of 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 • Inclusive family-forming support • Free on-site parking and gym facilities in the Waltham building

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