Senior Director, Biologics CMC

Senior Director, Biologics CMC(4 days onsite, 1 day remote)

While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required.
Position SummaryReporting 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 ResponsibilitiesProgram LeadershipServe 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 LeadershipProvide technical leadership for:Cell line developmentCell culture process developmentUpstream process optimizationDownstream purification developmentProcess characterizationTechnology transferGMP manufacturingProcess validation strategyComparability assessmentsManufacturing investigations and troubleshootingCross-functional CMC OversightMaintain sufficient scientific understanding to oversee and critically review:Drug product formulation developmentFill-finish manufacturingContainer closure selectionAnalytical method development and qualificationStability strategySpecification developmentReference standardsRaw material strategyCMC regulatory documentationAlthough 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 ManagementLead 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.RegulatorySupport preparation of:INDsIMPDsScientific Advice packagesHealth Authority responsesClinical trial amendmentsCMC risk assessmentsParticipate in Health Authority interactions as needed.
Required QualificationsPhD + 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 DevelopmentBroad 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. xzbcwsv Excellent scientific communication skills.
Preferred ExperienceExperience with one or more of:Monoclonal antibodiesBispecific antibodiesFusion proteinsAntibody fragmentsNovel biologic modalities