Senior Director, CMC Drug Substance Development & Manufacturing

Role Summary

Senior Director, CMC Drug Substance Development & Manufacturing is an experienced process chemist responsible for leading late-stage manufacturing of small molecule drug substances, overseeing technical transfer, process validation, and manufacturing activities. The role includes preparation and review of technical development reports and CMC sections of regulatory submissions (INDs, IMPDs, NDAs), and collaboration with QA/CMC Regulatory Affairs to ensure quality standards and regulatory compliance. Location is 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 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, for instance), 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 regulatory 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

• Ph.D. in Organic Chemistry or related discipline with a minimum of 12+ years of experience, or Master's with 15+ years 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 inquiries
• Effective written, oral communication and interpersonal skills
• Publications in peer-reviewed journals and patent applications are a plus

Education

• Ph.D. in Organic Chemistry, or related discipline with 12+ years of industry experience, or a Master’s with 15+ years in a CMC development organization

Additional Requirements

• Role based in San Francisco or Boston; travel approximately 10%