Director, Chemical Development

Responsibilities

• Lead and manage cross-functional teams engaged in external cGMP manufacturing of drug substance, DS intermediates, and starting materials.
• Collaborate with medicinal chemistry partners to support candidate selection and developability assessments. Advise and assist with sourcing scaffolds and intermediates as appropriate.
• Provide technical and functional project leadership on drug substance process development, manufacturing, and CDMO partner management.
• Oversee technical transfer activities between CDMOs as needed to ensure supply continuity.
• Collaborate with Analytical Development to ensure the development and validation of analytical test methods for drug substances.
• Ensure timely documentation review and approval to ensure supply continuity (Batch records, specifications, change controls, etc.).
• Provide technical input to deviation investigations to assess impact to product and manufacturing processes.
• Partner with Quality Assurance and CMC Regulatory to develop and implement appropriate processes and controls to ensure drug substance batches meet specifications and adhere to cGMP when required.
• Support investigations, root cause identification and CAPA implementation associated with manufacturing deviations and associated quality events.
• Work closely with Analytical Development/QC, Quality Assurance, Regulatory CMC, Supply Chain, and external manufacturing operations to ensure operational excellence with respect to timelines, budgets, and attainment of technical, regulatory and business goals/milestones.
• Author and review technical documents, process development reports, and drug substance sections for IND, IMPD, and global marketing applications.
• Stay current with applicable global regulations and industry standards.
• Represent Drug Substance and Chemical Development in meetings with FDA, EMA, and related regulatory authorities.
• May supervise one or more process chemists.

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 the Chemical Development of small-molecule pharmaceuticals.
• Demonstrated successful leadership in a pharmaceutical CMC drug substance development role.
• Track record of success in leading and managing small-molecule drug substance programs in a 100% outsourced environment.
• Strong vendor/supplier management skills and excellent communication and cross-functional collaboration skills.
• Broad experience working with and managing external CDMO partners, including use of performance and quality metrics and MSA negotiation.
• Expertise in small molecule process development and oversight of GMP manufacturing, including tech transfer and process validation.
• Experience authoring and reviewing technical documents including, but not limited to, development reports, master batch records, analytical testing methods, and specifications.
• Deep understanding of global regulatory requirements for the manufacture, testing, and control of drug substances.
• Demonstrated success with authoring drug substance sections of INDs, IMPDs, and marketing applications, and practice responding to inquiries from regulatory agency reviews.
• Strong project leadership skills with the ability to manage complex timelines, multiple stakeholders, and evolving program priorities.
• Exceptional communication and collaboration skills with a proven ability to work cross-functionally in a fast-paced, science-driven environment.
• Understanding of basic budgeting processes.
• Understanding of industry trends, practices, techniques and standards, and associated impact on program strategy and execution.
• Ability to travel (20%) to CDMO domestic and international sites.
• Fluency with standard computer software packages (MS Word, Excel, PowerPoint, and Project) and JMP (or similar statistical tools).
• High level of personal integrity, commitment to excellence and to our patients.
• Experience in developing and commercializing drugs for oncology is preferred.