Senior Director, CMC Drug Substance Development & Manufacturing

Role Summary

Senior Director, CMC Drug Substance Development & Manufacturing is an experienced process chemist who leads late-stage manufacturing of small molecule drug substances. Responsible for technical transfer, oversight of manufacturing activities, and preparation/review of CMC sections of 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 for familiarization, transfer, validation, and routine manufacturing
• Collaborate with CMC SMEs on development and validation of analytical test methods for drug substances
• Lead or support documentation review and approval (MBRs, specifications, analytical methods), change controls, and documentation for internal batch disposition
• Oversee investigations related to deviations and ensure timely closure
• Partner with Quality Assurance and CMC Regulatory Affairs to develop and operate CMC procedures ensuring quality standards and regulatory parameters
• Work with SMEs to execute shipment of drug substance batches
• Partner with supply chain to design API production schedules 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 global regulations and industry standards

Qualifications

• Required: Ph.D. in Organic Chemistry or related discipline with a minimum of 12+ years in a CMC development organization; or Master with a minimum of 15+ years
• Required: A minimum of 5+ years of direct people management and leadership experience
• Required: Demonstrated leadership in pharmaceutical CMC drug substance development
• Required: Broad experience with CDMOs and external development/manufacturing partners
• Required: Expertise in small molecule process development and GMP manufacturing oversight, including tech transfer and process validation
• Required: Understanding of supplier performance management, quality metrics, and familiarity with commercial supply agreement negotiations
• Required: Experience authoring/reviewing technical documents (development reports, master batch records, analytical methods, specifications)
• Required: Thorough understanding of global regulatory requirements for manufacture, testing, and control of clinical and commercial drug substances
• Required: Experience authoring drug substance sections of INDs, IMPDs, and marketing applications, and responding to regulatory inquiries
• Required: Effective written, oral communication and interpersonal skills
• Preferred: Publications in peer-reviewed journals and patent applications
• Attributes (Required): Highly analytical and detail-oriented; self-starter; goal- and data-driven; ability to multi-task and meet deadlines; collaborative cross-functionally
• Preferred: Demonstrated ability to lead cross-functional teams

Skills

• Strong project leadership and cross-functional collaboration
• Analytical method development and validation
• Technical writing and regulatory documentation
• Quality systems and deviation investigation management
• Supply chain and CDMO/vendor management

Education

• Ph.D. in Organic Chemistry or related discipline (or equivalent) with extensive CMC experience
• Alternative: Master’s degree with substantial (15+ years) CMC development experience

Additional Requirements

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