Senior Director, CMC Drug Substance Development & Manufacturing

Role Summary

Senior Director, CMC Drug Substance Development & Manufacturing is an experienced process chemist with a proven track record of successful project leadership and oversight of late-stage (registrational, process validation, commercial) manufacturing of small molecule drug substances. Responsible for the execution of technical transfer (including process validation activities), oversight of manufacturing activities, document review, and quality event support for drug substances, as well as the preparation and review of technical development reports and relevant CMC sections of regulatory submissions including INDs, IMPDs, and NDAs. Based in either San Francisco or Boston with travel requirements.

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 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 12+ years of experience, or Master with 15+ years of experience, in a CMC development organization
• Minimum 5+ years of direct people management and leadership experience
• Demonstrated successful leadership in a pharmaceutical CMC drug substance development role
• Broad experience 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 manufacture, testing, and control of clinical and commercial drug substances
• Demonstrated success with authoring drug substance sections of INDs, IMPDs, and marketing applications, with experience responding to regulatory inquiries
• Effective written, oral communication and interpersonal skills
• Publications in peer-reviewed journals and patent applications

Skills

• Analytical thinking, cross-functional collaboration, and strong initiative
• Ability to work independently and manage multiple priorities to meet deadlines
• Strong documentation and technical writing abilities
• Excellent communication and interpersonal skills
• Experience with regulatory interactions and technical development reporting

Education

• Ph.D. in Organic Chemistry or related discipline (preferred) or equivalent advanced degree with relevant CMC experience

Additional Requirements

• 10% travel