Director Drug Product Development

Client is seeking an experienced Director, Drug Product Development, to be based in their Northern NJ Office. This role will lead drug product strategy and execution across our clinical-stage portfolio, supporting the advancement of innovative therapies for patients with serious rare diseases.

Position Summary:

The Director, Drug Product Development will lead formulation, manufacturing, and lifecycle activities for drug product candidates from development through clinical-stage execution. This role partners across CMC, Quality, Regulatory, Supply Chain, and external manufacturers to ensure drug products are robust, scalable, and aligned with program timelines and regulatory requirements.

Responsibilities:

·Drug Product Development Strategy: Lead drug product development strategy across the clinical-stage portfolio, including formulation design, process development, manufacturability, and lifecycle planning.

• Formulation & Clinical Supply Execution: Develop and optimize scalable dosage forms and manufacturing processes to support clinical studies, technical transfers, and reliable product supply. Conduct drug product risk assessment and develop risk mitigation plans.
• External Manufacturing Leadership: Select, oversee, and manage CDMOs, CMOs, and other external partners to ensure timely execution, quality performance, and alignment with program objectives.
• CMC Regulatory Support: Contribute to CMC strategy and author, review, or support regulatory submissions and responses, amendments, briefing documents, and other health authority interactions as needed.
• Cross-Functional Program Leadership: Partner closely with Analytical Development, Drug Substance, Quality, Regulatory, Clinical Operations, and Supply Chain to align technical plans with development timelines, budgets, and program priorities.
• Technical Representation & Governance: Represent drug product development in internal governance forums and external meetings with manufacturers, auditors, consultants, and development partners, serving as a key technical leader for product-related decisions.

Requirements and Preferred Skills:

·Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or related Physical Sciences with at least 12 years of experience, or M.S. with 15 years of experience working in drug product development in the pharmaceutical or biotechnology industry.

• In-depth knowledge and hands-on experience leading drug product development and CMC activities for small molecule programs in a clinical-stage biotechnology or pharmaceutical environment.
• Demonstrated success advancing programs through key development milestones, including clinical trial supply, process scale-up, technology transfer, and regulatory submissions.
• Strong working knowledge of CMC regulatory requirements and development expectations for IND-enabling and clinical-stage programs. Proven experience writing CMC drug product sections in regulatory submissions.
• Experience managing CDMOs, CMOs, and other external development and manufacturing partners, with the ability to drive accountability, timelines, and quality outcomes.
• Broad cross-functional CMC expertise, with the ability to work effectively across Drug Substance, Analytical, Quality, Regulatory, Supply Chain, and Clinical teams.
• Excellent written and verbal communication skills, including the ability to communicate complex technical issues clearly to internal and external stakeholders.
• Strong leadership, judgment, and problem-solving skills, with the ability to operate effectively in a fast-paced, resource-conscious, entrepreneurial environment.
• Proven ability to build productive relationships with external partners, consultants, and scientific advisors.
• Experience mentoring team members and contributing to a collaborative, high-accountability culture is preferred.