Cogent Biosciences

Cogent Biosciences

Senior Director, Commercial Manufacturing, Science and Technology

Remote, United States · Director

Sponsorship not specified$240k-$280kDetected 62 days ago
Supply ChainGMPFDA RegulatoryResearchLeadershipCommunicationCollaborationMentoringPublic Speaking

About the role

  • 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.
  • Analyze existing processes, identify areas for improvement, and implement innovative technologies and strategies to optimize yield, reduce costs, and enhance efficiency.
  • Lead cross functional teams to resolve technical challenges and meet program expectations, including Reg CMC and Quality Assurance.
  • 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
  • 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.

Requirements

  • 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
  • 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.
  • 8+ years of management and oversight of CDMOs for cGMP activities
  • Familiarity with safe and efficient laboratory practices
  • General and scientific computer and software application proficiency
  • 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.
  • 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
  • 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.
  • 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.
  • Ability to navigate and craft global regulatory CMC documents
  • 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.

Compensation

  • $240,000 - 280,000 USD
  • Exact compensation will vary based on skills, experience, and location.
  • At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that se t s us apart.

Benefits

  • At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that se t s 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.
  • A dditional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.

Company info

  • 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.
  • 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.
  • We are proud to be an

Equal opportunity

  • We are proud to be an Equal Opportunity Employer.
  • Our goal is to have a diverse workforce.
  • Equal Opportunity Employer.
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This listing is sourced directly from Cogent Biosciences's careers page and normalized into a canonical job model.