Senior Director, CMC Drug Substance Development & Manufacturing

Role Summary

Senior Director, CMC Drug Substance Development & Manufacturing responsible for leading drug substance process development, manufacturing, and CMO management for late-stage programs. Based in San Francisco or Boston with travel up to 10%. Oversee technical transfer, process validation, documentation reviews, and CMC regulatory submissions (INDs, IMPDs, NDAs).

Responsibilities

• Provide technical and functional project leadership on drug substance process development, manufacturing, and CMO management
• Create and disseminate technical transfer information and documentation required for familiarization, transfer, validation and routine manufacturing
• Collaborate with SMEs within the CMC department on the development and validation of analytical test methods for drug substances
• Lead or support documentation review and approval (MBRs, specifications, analytical methods, etc.), change controls and documentation for internal batch disposition
• Oversee investigations related to deviations to assess impact to product and manufacturing process; ensures timely closure of such investigations
• Partner with Quality Assurance and CMC Regulatory Affairs SMEs to develop and operate appropriate CMC procedures to ensure the drug substance meets established quality standards and adheres to established and regulatory agency approved parameters
• Work closely with SMEs to execute shipment of drug substance batches
• Partner with supply chain teams to design API production schedules while maximizing production and cost efficiencies
• Author and review technical documents, process development reports, and drug substance sections for IND, IMPD and global marketing applications
• Stay current with state-of-the art approaches and applicable global regulations and industry standards

Qualifications

• Required: Ph.D. in Organic Chemistry or related discipline with 12+ years of experience, or Master with 15+ years of experience in a CMC development organization
• Required: at least 5+ years of direct people management and leadership experience
• Required: demonstrated successful leadership in a pharmaceutical CMC drug substance development role
• Required: broad experience working with CDMOs and managing external development and manufacturing partners
• Required: expertise in small molecule process development and oversight of GMP manufacturing, including tech transfer and process validation
• Required: understanding of supplier performance management and familiarity with commercial supply agreement negotiations
• Required: experience authoring and reviewing technical documents including development reports, master batch records, analytical testing methods, and specifications
• Required: thorough understanding of global regulatory requirements for manufacture, testing, and control of clinical and commercial drug substances
• Required: demonstrated success with authoring drug substance sections of INDs, IMPDs, and marketing applications, and ability to respond to regulatory inquiries
• Required: effective written, oral communication and interpersonal skills
• Required: publications in peer-reviewed journals and patent applications
• Preferred: ability to collaborate effectively within cross-functional teams; highly analytical and detail oriented; self-starter; goal- and data-driven; ability to multi-task and shift priorities to meet deadlines; commitment to high scientific and ethical standards; motivation to improve processes

Skills

• Strong leadership and project management
• Technical transfer, process development, and validation expertise
• Analytical method development and validation
• Documentation, regulatory writing, and submissions (INDs, IMPDs, NDAs)
• Quality systems, deviation investigations, and change control
• Vendor management andSupply chain coordination

Education

• Ph.D. in Organic Chemistry or related field with 12+ years of CMC development experience, or
• Master’s degree with 15+ years of CMC development experience

Additional Requirements

• Location: San Francisco or Boston
• Travel: up to 10%