Senior Director, Commercial Manufacturing, Science and Technology at Cogent Biosciences

Remote, United StatesFull-timeRemoteCMCPosted 22 days ago

About the Role

Who We Are: 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.  <hr> The Role: This position oversees late phase through commercialization small molecule drug product manufacturing at partner Contract Development and Manufacturing Organizations (CDMOs) and ensures high-quality products are delivered on time and within budget.  Serve as a technical expert who leads the transfer of manufacturing processes to commercial scale.  Manage processes, systems and infrastructure that meet safety, cGMP manufacturing, and regulatory compliance.  Provide technical expertise and oversight for process validation, lifecycle management, and continuous improvement.  Anticipate and solve complex manufacturing issues.  Work in collaboration with internal and external stakeholders including CMC, Quality, Supply Chain and Regulatory, as well as CDMOs. <hr> Responsibilities: <div> <ul> <li>Lead commercial drug product CMC lifecycle activities such as post-approval change management, process validation product risk management and process monitoring.</li> <li>Facilitate technology transfers, ensuring successful scale-up to commercial-scale production environments. </li> <li>Serve as Primary technical point of contact with the CDMO's. Establish and monitor KPI's.</li> <li>Analyze existing processes, identify areas for improvement, and implement innovative technologies and strategies to optimize yield, reduce costs, and enhance efficiency. </li> <li>Provide technical expertise and actively troubleshoot and solve complex technical problems that arise during production. </li> <li>Lead cross functional teams to resolve technical challenges and meet program expectations, including Reg CMC and Quality Assurance.</li> <li>Ensure that all manufacturing processes comply with relevant regulations and guidelines, including cGMP.</li> <li>Provide strategic leadership by directing and mentoring staff and fostering a culture of quality and innovation. </li> <li>Drive continuous improvement, implement best practices, and optimize manufacturing for efficiency and cost-effectiveness. </li> </ul> <ul> <li>Provide regulatory filings support by authoring and reviewing CMC sections of IND, IMPD, NDA or other filings as</li> </ul> <hr> Qualifications: <ul> <li>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</li> <li>20+ years of biotechnology and/or pharmaceutical industrial experience in CMC/cGMP environment</li> </ul> <ul> <li>12+ years of management and oversight of CDMOs for cGMP activities for late stage and commercial assets</li> <li>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.</li> <li>Extensive experience in outsourcing, vendor selection and managing CMOs for scale up, tech transfer, process validation, and commercial manufacturing.</li> <li>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.</li> <li>Excellent oral and written communication skills for presenting in project meetings, vendor discussions, and writing technical reports and regulatory filings.</li> <li>Attention to detail and quality with critical thinking.</li> <li>20+ years of biotechnology and/or pharmaceutical industrial experience in CMC/cGMP environment</li> <li>8+ years of management and oversight of CDMOs for cGMP activities</li> <li>Ability to navigate and craft global regulatory CMC documents</li> <li>Familiarity with safe and efficient laboratory practices</li> <li>General and scientific computer and software application proficiency</li> <li>Up to 30% travel.</li> <li>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.</li> <li>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.</li> </ul> <hr> Salary Range: $240,000 - 280,000 USD  <div>Target Bonus: 25%</div> <div>Exact compensation will vary based on skills, experience, and location.</div> <div><hr></div> <div> <div>Our Locations</div> <div> 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.  <hr> Our Offer To You  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.  We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.  </div> </div>   </div>

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