Associate Director, Chemical Development

About The Role

The Associate Director, Chemical Development will support the strategic planning and execution of CMC activities related to drug substance development and manufacturing at CMOs from preclinical through commercialization. Reporting to the Director of Chemical Development, this role will provide technical and operational leadership for assigned programs and collaborate closely with Technical Operations, Pharmaceutical Sciences, Analytical Development, Quality, Regulatory Science, and Supply Chain to support the continuous supply of clinical and commercial products.

Responsibilities

• Manage API operations across assigned CMC programs and ensure operational plans align with regulatory, program, and corporate strategies.

• Oversee the manufacture of clinical and commercial drug substance at CMOs and drive adherence to project timelines, quality requirements, and supply objectives.

• Build and maintain effective working relationships with external manufacturing partners.

• Partner with CMOs to plan and execute manufacturing initiatives, including CMO site selection, technology transfer, scale-up, process development and optimization, validation, and clinical and commercial production.

• Support the development of robust supply strategies for clinical and commercial drug substance.

• Identify technical and operational risks and implement mitigation plans aligned with overall development timelines.

• Collaborate with internal functional groups to ensure manufacturing activities comply with cGMP requirements and regulatory filings.

• Lead or support the timely investigation and resolution of deviations and other manufacturing issues.

• Develop and manage budgets and forecasts for assigned CMC activities.

• Partner with the Director of Chemical Development and Finance to monitor spend and address budget variances.

• Collaborate with Regulatory Science and the Director of Chemical Development to develop CMC strategies.

• Author and review relevant sections of CMC regulatory submissions and responses to health authority questions.

• Collaborate with Pharmaceutical Sciences and cross-functional partners to develop and execute drug substance development strategies.

• Review and approve, as appropriate, drug substance manufacturing batch records, protocols, reports, specifications, change controls, and deviations.

• Coverage and provide on-site or remote technical oversight for manufacturing activities, as needed.

Qualifications

• B.S., M.S., or Ph.D. in a relevant engineering or scientific discipline.
• Strong understanding of the technical and scientific challenges associated with drug substance development and pharmaceutical manufacturing.
• Experience supporting sterile product programs and related manufacturing operations is preferred.
• Ph.D. in Technical Operations, chemical development, process development, or pharmaceutical manufacturing support with 8+ years of progressive industrial experience or a B.S. with 12+ years, or an M.S. with 10+ years.
• Experience in several of the following areas is preferred: small-molecule or other API modalities, intermediates and regulatory starting materials, CMO selection and oversight, technology transfer, process development and optimization, scale-up, registration, validation, and commercial manufacturing.
• Strong project management, technical problem-solving, and business skills, with the ability to manage multiple priorities, external partners, budgets, and timelines.
• Demonstrated ability to lead cross-functional teams and external partners, influence without direct authority, mentor colleagues, and communicate effectively across technical and business functions.
• Translates program and department strategy into practical execution plans; adjusts priorities and tactics in response to changing program needs, technical information, and business circumstances.