Senior Director, CMC Drug Substance Development & Manufacturing

Role Summary

The Senior Director of CMC Drug Substance Development & Manufacturing is an experienced process chemist responsible for leading late-stage drug substance development and manufacturing activities, including technical transfer, process validation, and management of CMOs. This role oversees manufacturing operations, document review, and quality event support, and is responsible for preparation and review of technical development reports and CMC sections of regulatory submissions (INDs, IMPDs, NDAs, etc.). The position is based in San Francisco or Boston with 10% travel.

Responsibilities

• Provide technical and functional project leadership on drug substance process development, manufacturing, and CMO management
• Create and disseminate technical transfer information and documentation for familiarization, transfer, validation, and routine manufacturing
• Collaborate with SMEs within the CMC department on 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; ensure timely closure of investigations
• Partner with Quality Assurance and CMC Regulatory Affairs SMEs to develop and operate CMC procedures to ensure drug substance meets quality standards and regulatory parameters
• Work 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

• Ph.D. in Organic Chemistry or related discipline with a minimum of 12+ years of experience, or Master with a minimum of 15+ years of experience, in a CMC development organization
• A minimum of 5+ years of direct people management and leadership experience
• Demonstrated successful leadership in a pharmaceutical CMC drug substance development role
• Broad experience working with CDMOs and managing external development and manufacturing partners
• Expertise in small molecule process development and oversight of GMP manufacturing, including tech transfer and process validation
• Understanding of supplier performance management and familiarity with commercial supply agreement negotiations
• Experience authoring and reviewing technical documents including development reports, master batch records, analytical testing methods, and specifications
• Thorough understanding of global regulatory requirements for the manufacture, testing, and control of clinical and commercial drug substances
• Demonstrated success with authoring drug substance sections of INDs, IMPDs, and marketing applications, and experience responding to regulatory agency inquiries
• Effective written, oral communication and interpersonal skills
• Publications in peer-reviewed journals and patent applications

Skills

• Strong project leadership and cross-functional collaboration
• Analytical thinking with attention to detail
• Technical transfer and process validation expertise
• Regulatory documentation and inspection readiness
• Supplier and vendor management

Education

• Ph.D. in Organic Chemistry, or related discipline, or Master’s degree with extensive CMC development experience

Additional Requirements

• Travel: approximately 10% based in San Francisco or Boston