Senior Director, Biologics CMC(4 days onsite, 1 day remote)
Position Summary:
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 clinicaldevelopment. This individual will possess deep technical expertise in cell line development(CLD), upstream and downstream process development (Drug Substance), while maintainingbroad working knowledge across all CMC disciplines including formulation, drug productmanufacturing, analytical development, quality, regulatory CMC, and external manufacturing. Because we are a lean, science-driven organization, this role requires a highly collaborativeleader who is equally comfortable with hands-on activities, leading technical discussions, reviewing experimental data, authoring technical documents, and managing external partners.
Primary Responsibilities
Program Leadership:- 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 line development
- Cell culture process development
- Upstream process optimization
- Downstream purification development
- Process characterization
- Technology transferGMP manufacturing
- Process validation strategy
- Comparability assessments
- Manufacturing investigations and troubleshooting
- Cross-functional CMC Oversight
- Maintain sufficient scientific understanding to oversee and critically review:
- Drug product formulation development
- Fill-finish manufacturing
- Container closure selection
- Analytical method development and qualification
- Stability strategy
- Specification development
- Reference standards
- Raw material strategyCMC regulatory documentation
- Although not expected to be the subject matter expert in every discipline, the individual must becapable 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:
INDsIMPDsScientific Advice packages
Health Authority responses
Clinical trial amendmentsCMC risk assessments
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 CMCExperience 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.
- Preferred Experience
- Experience with one or more of:
- Monoclonal antibodies
- Bispecific antibodies
- Fusion proteins
- Antibody fragments
- Novel biologic modalities
