Senior Director, Biologics CMC
Listed on 2026-07-25
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Pharmaceutical
Regulatory Compliance Specialist, Pharmaceutical Science/ Research
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, develop ability assessment, and IND-enabling activities and throughout clinical development stages.
- Represent CMC on multidisciplinary project teams.
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
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.
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.
- Cell Line Development, Upstream Development, Downstream Process Development
- 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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