Senior Director, Commercial Manufacturing, Science and Technology

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. 

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.

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

Qualifications:

• 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.
• 20+ years of biotechnology and/or pharmaceutical industrial experience in CMC/cGMP environment
• 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 o