Senior Director, Biologics CMC

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

Reporting to the Head of CMC, the Senior Director, Biologics CMC will provide scientific, operational and strategic leadership for biologics CMC from late discovery through clinical development. This individual will possess deep technical expertise in cell line development (CLD), upstream and downstream process development (Drug Substance), while maintaining broad working knowledge across all CMC disciplines including formulation, drug product manufacturing, analytical development, quality, regulatory CMC, and external manufacturing.

Because we are a lean, science-driven organization, this role requires a highly collaborative leader who is equally comfortable with hands‑on activities, leading technical discussions, reviewing experimental data, authoring technical documents, and managing external partners.

Primary Responsibilities

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

Drug Substance Leadership

Provide technical leadership for:

• Cell culture process development
• Upstream process optimization
• Process characterization
• Technology transfer
• GMP manufacturing
• Process validation strategy
• Comparability assessments
• Manufacturing investigations and troubleshooting

Cross-functional CMC Oversight

Maintain sufficient scientific understanding to oversee and critically review:

• Fill‑finish manufacturing
• Container closure selection
• Analytical method development and qualification
• Stability strategy
• Reference standards
• Raw material strategy
• CMC regulatory documentation

Although not expected to be the subject matter expert in every discipline, the individual must be capable of integrating all CMC functions into a cohesive development strategy.

External Partner Management

• Lead scientific oversight of CDMOs and CROs.
• Review protocols, reports, manufacturing records, development plans and technical deliverables.
• Drive technical decision making with external partners.
• Monitor timelines, budgets, risks and deliverables.
• Build strong collaborative relationships with external manufacturing organizations.

Regulatory

Support preparation of:

• INDs
• IMPDs
• Scientific Advice packages
• Health Authority responses
• Clinical trial amendments

Participate in Health Authority interactions as needed.

Required Qualifications

• PhD + 12 years / MS + 15 years: Advanced degree (PhD preferred) in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline, with a minimum of 12 years (PhD) or 15 years (MS/BS) of biologics CMC industry experience.
• PhD or MS in Chemical Engineering, Biochemical Engineering, Biochemistry, Biotechnology or related discipline.
• Typically 12+ years of biologics CMC development experience.

Deep expertise in one or more of:

• Cell Line Development, Upstream Development, Downstream Process Development

Broad understanding of:

• Formulation, Drug Product manufacturing, Analytical Development, Quality systems, Regulatory CMC
• Experience supporting biologics from late discovery through multiple clinical phases.
• Demonstrated experience managing global CDMOs.
• Strong knowledge of ICH and global CMC regulatory expectations.
• Excellent scientific communication skills.