Director, Drug Product Development - Clinical-Stage Leader

The Steely Group; Jersey City (NJ); Hybride; USD 200 000 - 350 000; Plein temps

Résumé du poste

The Steely Group is seeking an experienced Director, Drug Product Development, to lead formulation, manufacturing, and lifecycle activities for drug product candidates from development through clinical-stage execution in the Jersey City, NJ office.

This role partners across CMC, Quality, Regulatory, Supply Chain, and external manufacturers to ensure robust, scalable products that meet program timelines, quality standards, and regulatory expectations.

Qualifications

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or related Physical Sciences with at least 12 years of experience, or MS with 15 years.
• Experience leading drug product development and CMC activities for small molecule programs in clinical-stage settings.
• Strong knowledge of CMC regulatory requirements and development expectations for regulatory submissions.
• Experience managing CDMOs, CMOs, and other external development and manufacturing partners.

Responsabilités

• Lead drug product development strategy across the clinical-stage portfolio.
• Develop scalable dosage forms and manufacturing processes for clinical studies and tech transfers.
• Oversee external partners (CDMOs/CMOs) to ensure quality, timelines and program objectives.
• Contribute to CMC regulatory strategy and regulatory submissions and responses.
• Collaborate across Analytical Development, Drug Substance, Quality, Regulatory, Supply Chain and Clinical teams.
• Represent drug product development in governance forums and external meetings with partners.

Connaissances

CMC leadership

Regulatory submissions

Cross-functional collaboration

Strategic planning

Formation

Ph.D. in Pharmaceutical Sciences or Chemical Engineering

M.S. in related field with 15 years experience

Description du poste

The Steely Group is seeking an experienced Director, Drug Product Development, to lead formulation, manufacturing, and lifecycle activities for drug product candidates from development through clinical-stage execution in the Jersey City, NJ office.

This role partners across CMC, Quality, Regulatory, Supply Chain, and external manufacturers to ensure robust, scalable products that meet program timelines, quality standards, and regulatory expectations.