Senior Director, Biologics CMC — Lead CLD & Process Dev

GTS Scientific; New York (NY); On-site; USD 210,000 - 350,000; Full time

Job summary

GTS Scientific in New York seeks a Senior Director, Biologics CMC to lead scientifically and operationally from late discovery through clinical development. The role requires deep CLD, upstream and downstream expertise and broad CMC knowledge across formulation, manufacturing, analytics, quality and regulatory CMC.

This collaborative leader will manage external partners, author technical documents, and drive integrated CMC strategies with cross-functional teams in a lean, science-driven

Qualifications

• PhD or MS with 12+ years biologics CMC industry experience.
• Deep expertise in cell line development, upstream and downstream process development.
• Experience leading external CDMOs and cross-functional teams.

Responsibilities

• Serve as the CMC technical lead for biologics programs from late discovery through clinical development.
• Develop and execute integrated CMC strategies aligned with program objectives.
• Provide leadership during candidate selection, developability, IND-enabling activities and clinical development.
• Represent CMC on multidisciplinary project teams.

Skills

Biologics CMC leadership

Cell line development

Upstream process development

Downstream process development

Regulatory CMC knowledge

Cross-functional leadership

Education

PhD in Biochemistry / Biochemical Engineering

MS in Chemical Engineering / Biotechnology

Job description

GTS Scientific in New York seeks a Senior Director, Biologics CMC to lead scientifically and operationally from late discovery through clinical development. The role requires deep CLD, upstream and downstream expertise and broad CMC knowledge across formulation, manufacturing, analytics, quality and regulatory CMC.

This collaborative leader will manage external partners, author technical documents, and drive integrated CMC strategies with cross-functional teams in a lean, science-driven