Sr. Director/Director, CMC Lead

We are partnered with a leading Clinical Stage Biotech that is seeking an experienced Sr. Director/Director, CMC Lead to provide strategic and operational leadership for all Chemistry, Manufacturing & Controls (CMC) activities across one or more small molecule development programs.

Responsibilities

• CMC Strategy & Program Leadership
  • Develop and execute integrated CMC strategies supporting clinical and commercial development objectives.
  • Serve as the CMC representative on program teams and provide technical leadership across all CMC disciplines.
  • Lead CMC planning, risk assessments, timelines, budgets, and milestone execution.
  • Identify and mitigate technical, manufacturing, regulatory, and supply chain risks.
• Drug Substance & Drug Product Oversight
  • Oversee small molecule API development, process optimization, scale-up, technology transfer, and manufacturing.
  • Provide strategic oversight of formulation development, process development, and commercial readiness activities.
  • Ensure phase-appropriate control strategies are established and maintained.
  • Support lifecycle management and commercial manufacturing strategies.
• Partner Management
  • Partner with functional leads of Process Chemistry, Analytical Development, and Formulation to ensure all technical workstreams are progressing according to plan, with clear deliverables and interdependencies.
  • Lead selection, qualification, and oversight of CDMOs, CROs, analytical laboratories, and other external partners.
  • Manage technical interactions and governance with external manufacturing organizations.
  • Monitor project execution, timelines, budgets, and deliverables.
• Regulatory CMC
  • Author, review, and approve CMC sections of regulatory submissions including: INDs, IMPDs, NDAs and BLAs.
  • Support agency interactions and regulatory inspections as needed.
  • Ensure compliance with FDA, EMA, and ICH requirements.
• Budget & Resource Management
  • Develop and manage CMC budgets.
  • Maintain forecasting and resource planning across development programs.
  • Evaluate outsourcing strategies and vendor performance.

Requirements

• Ph.D. or MS in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.
• 12+ years of progressive experience within the pharmaceutical or biotechnology industry, including leadership responsibilities across multiple CMC functions.
• Demonstrated success leading cross-functional CMC teams supporting small molecule development programs from IND-enabling activities through late-stage development and commercial readiness.
• Strong understanding of Drug Substance, Drug Product, Analytical Development, Manufacturing, Quality, and Regulatory CMC requirements.
• Extensive experience interacting with CDMOs, and external development and manufacturing partners.
• Thorough knowledge of FDA, EMA, ICH, and global regulatory requirements governing pharmaceutical development and commercialization.
• Proven track record supporting successful IND, NDA, and other global regulatory submissions.
• Exceptional leadership, communication, organizational, and stakeholder management skills.
• Ability to operate effectively within a fast-paced, highly collaborative, outsourced biotech environment.
• Experience balancing strategic leadership with hands-on execution in a lean and rapidly evolving organization.