Senior Director, CMC & Pharmaceutical Development

Clinical Dynamix, Inc.; Jersey City (NJ); On-site; USD 250,000 - 320,000; Full time

Job summary

Clinical Dynamix, Inc. seeks an Executive Director of CMC/Pharmaceutical Development to oversee all CMC activities from preclinical through commercial supply. You will lead process development, manufacturing, analytics, and technology transfer, while coordinating with CMOs and regulatory teams to ensure compliant filings.

The role demands 15+ years in drug development, a PhD, and proven leadership of multidisciplinary CMC programs, with a focus on IV formulations and scalable processes.

Qualifications

• PhD in a relevant scientific discipline with 15+ years in drug substance and drug product development.
• Proven leadership of CMC teams across API/DP and regulatory submissions.
• Experience managing CMOs and global regulatory filings (IND/IMPD, NDA/MAA).
• Strong expertise in fermentation, purification, and IV formulation development.
• Track record of developing scalable, robust manufacturing processes.

Responsibilities

• Lead CMC group including Supply chain and cross-functional teams.
• Oversee drug substance/product process development, manufacturing, and analytics.
• Identify and manage CMOs for API/DP development and manufacturing.
• Develop scalable manufacturing processes for clinical and commercial supply.
• Manage technology transfer to CMOs and external partners.
• Own CMC sections in global regulatory filings and IND/IMPD/NDA/MAA work.
• Lead budgeting, project status, and collaboration with project teams.

Skills

Leadership

CMC strategy

Regulatory submissions

Project management

Technology transfer

Vendor management

Cross-functional

Drug development

Education

PhD in a relevant scientific discipline

Job description

Clinical Dynamix, Inc. seeks an Executive Director of CMC/Pharmaceutical Development to oversee all CMC activities from preclinical through commercial supply. You will lead process development, manufacturing, analytics, and technology transfer, while coordinating with CMOs and regulatory teams to ensure compliant filings.

The role demands 15+ years in drug development, a PhD, and proven leadership of multidisciplinary CMC programs, with a focus on IV formulations and scalable processes.