Cogent Biosciences - Director, Drug Substance Manufacturing & Development
Requirements
• Degree in Organic chemistry - Bachelor’s/Master’s degree with 12+ years of experience or PhD degree with 8+ years of experience. • Subject matter expert in small molecule drug substance production techniques, processing, and characterization and have a demonstrated track record of successful CDMO management. • Extensive experience in small molecule cGMP manufacturing and proficient knowledge of ICH Q7 guidelines. • Experience in evaluating and setting phase appropriate controls including raw material, in-process, intermediate, and final drug substance specifications. Familiar with ICH guidelines as they relate to these controls. • History writing, reviewing and approving quality documents (batch records, SOPs, change controls) and participating in quality events (deviation investigation, CAPA, audits). • Experience writing, reviewing and approving technical documents including development reports, risk assessments, and regulatory drug substance sections (IND, IMPD,NDA). • Working knowledge of solid-state development and characterization. The ability to lead polymorph, salt/co-crystal evaluation, and selection. Familiar with the use of XRPD, DSC, TGA, DVS, PSD, and microscopy to support characterization. • Ability to collaborate with diverse stakeholders, both internally and external contract manufacturers. • Detail oriented with strong written and oral communication skills and proven history of working with others in a multidisciplinary team environment. • Ability to troubleshoot problems, work within a team. • Ability to manage multiple projects simultaneously, creative in developing strategies for solving problems, and is driven by project requirements such as milestones and timelines. • Ability to travel internationally and within the USA up to 10 – 30%, as required, to meet project objectives.
Responsibilities
• Subject matter expert for all aspects of drug substance process and controls. • Manage development and manufacturing activities at drug substance CDMOs. • Lead small molecule drug substance route selection/evaluation, scale up, and process control development including identification of critical process parameters, critical quality attributes, and acceptance criteria. • Review and approve external vendor documentation including protocols, reports, raw data, master and executed batch records. • Perform impurities fate analysis and manufacturing process parameters assessment and develop an overall end-to-end control strategy. • Lead solid state evaluation and development activities to support process control, formulation development, and intellectual property protection. • Provide drug substance support for quality events including deviation investigation, corrective and preventative action implementation and change control for both internal and external operations. • Author, review, and approve documents in support of regulatory filings including module 3 sections of Investigational New Drug (IND) applications and New Drug Application (NDA) as well as CMC section in a global regulatory submission. • Provide guidance as a subject matter expert in drug substance manufacturing and development for internal CMC and discovery organization. • Provide on-site support at external suppliers including project initiation, routine visits and technical leadership as needed.
Benefits
• $210,000 - 240,000 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 biopharmaceutical corridor, this office plays a central role in advancing our discovery efforts and pipeline. • At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that sets us apart. We cover 100% of medical, dental, and vision premiums for you and your family, and help reduce out-of-pocket costs by funding up to 75% of in-network deductibles. Our benefits also include a 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, and company-paid short-term disability coverage for up to 20 weeks. Additional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.
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