Cogent Biosciences - Senior Director, Commercial Manufacturing, Science and Technology
Requirements
• PhD, MS or BS in chemical engineering, pharmaceutical sciences or related field with an exceptional understanding of drug product development and manufacturing for small molecule solid oral dosage forms • 20+ years of biotechnology and/or pharmaceutical industrial experience in CMC/cGMP environment • 12+ years of management and oversight of CDMOs for cGMP activities for late stage and commercial assets • Experience in manufacturing techniques such as advanced drug delivery systems for enhancing drug permeability and/or solubility and other manufacturing processes including blending, granulation, tablet compression, film coating etc. • Extensive experience in outsourcing, vendor selection and managing CMOs for scale up, tech transfer, process validation, and commercial manufacturing. • Extensive knowledge of cGMP requirements for drug product manufacture as well as broader drug development guidelines (ICH, FDA, and EMA) and past experience in regulatory filings. • Excellent oral and written communication skills for presenting in project meetings, vendor discussions, and writing technical reports and regulatory filings. • Attention to detail and quality with critical thinking. • 8+ years of management and oversight of CDMOs for cGMP activities • Ability to navigate and craft global regulatory CMC documents • Familiarity with safe and efficient laboratory practices • General and scientific computer and software application proficiency • Up to 30% travel. • This position requires technical leadership skills; interaction with all levels of employees; and the ability to direct, coach, and evaluate the operational activities of lower-level employees as well as influencing others in a matrix team leadership environment. • Manages the coordination of the activities of a section or department with responsibility for results. In some instances, this manager may be responsible for a functional area and not directly supervise employees.
Responsibilities
• Lead commercial drug product CMC lifecycle activities such as post-approval change management, process validation product risk management and process monitoring. • Facilitate technology transfers, ensuring successful scale-up to commercial-scale production environments. • Serve as Primary technical point of contact with the CDMO's. Establish and monitor KPI's. • Analyze existing processes, identify areas for improvement, and implement innovative technologies and strategies to optimize yield, reduce costs, and enhance efficiency. • Provide technical expertise and actively troubleshoot and solve complex technical problems that arise during production. • Lead cross functional teams to resolve technical challenges and meet program expectations, including Reg CMC and Quality Assurance. • Ensure that all manufacturing processes comply with relevant regulations and guidelines, including cGMP. • Provide strategic leadership by directing and mentoring staff and fostering a culture of quality and innovation. • Drive continuous improvement, implement best practices, and optimize manufacturing for efficiency and cost-effectiveness. • Provide regulatory filings support by authoring and reviewing CMC sections of IND, IMPD, NDA or other filings as
Benefits
• $240,000 - 280,000 USD • Target Bonus: 25% • 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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