Cogent Biosciences
biotechnology
SeniorDirector,CommercialManufacturing,ScienceandTechnology
“Senior Director, Commercial Manufacturing, Science and Technology at Cogent Biosciences. Skills: Commercial Drug Product CMC Lifecycle Management, Technology Transfers, CDMO Management, Process Validation, cGMP Compliance, Regulatory Filings Support. oversees late phase through commercialization small molecule drug product manufacturing at partner Contract Development and Manufacturing Organizations (CDMOs). ensures high-quality products are delivered on time and within budget”
What You'll Achieve.
ensures high-quality products are delivered on time and within budget; optimize yield, reduce costs, and enhance efficiency.; meet program expectations
Industry & Context.
Anticipate and solve complex manufacturing issues.; troubleshoot and solve complex technical problems that arise during production.
Up to 30% travel.
What They're Looking For.
Must Have
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, technical leadership interaction with all levels of 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.
Nice to Have
Target Bonus: 25%
What You'll Do.
oversees late phase through commercialization small molecule drug product manufacturing at partner Contract Development and Manufacturing Organizations (CDMOs)
ensures high-quality products are delivered on time and within budget
leads the transfer of manufacturing processes to commercial scale
systems and infrastructure that meet safety
and regulatory compliance.
Provide technical expertise and oversight for process validation
and continuous improvement.
Anticipate and solve complex manufacturing issues.
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
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
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
NDA or other filings as
How You'll Work.
Team & Collaboration
Work in collaboration with internal and external stakeholders including CMC, Quality, Supply Chain and Regulatory, as well as CDMOs.; Lead cross functional teams to resolve technical challenges and meet program expectations, including Reg CMC and Quality Assurance.; influencing others in a matrix team leadership environment.
Communication Scope
Excellent oral and written communication skills for presenting in project meetings, vendor discussions, and writing technical reports and regulatory filings.
Process & Methodology
Manage processes, systems and infrastructure, Manage the coordination of the activities of a section or department with responsibility for results.
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