About this opportunity
GTS Scientific lists this Senior Director, Biologics CMC opportunity in new york, New York. Review the employer’s description below for duties, qualifications and application requirements.
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.
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Worksite address
new york, NY, 10261, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.