Senior Specialist, Process Support Lab
Core
Lead a team of scientists and engineers to execute lab-scale vaccine process development, technical transfer, and post-commercial process enhancements for pipeline vaccine programs.
Role type
Senior Specialist, Process Support Lab (Team Lead)
Builds
Lab-scale vaccine processes, scale-down models, and qualification studies for bulk vaccine products
Domain
Biopharmaceuticals / Vaccine Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
People management, analytical assay execution, statistical data analysis, technical writing, lab operations leadership, process characterization, deviation management
Preferred skills
cGMP manufacturing support, regulatory filing documentation, Design of Experiment (DOE), digital visualization tools, scientific mentorship
Technologies
SoloVPE, Lighthouse, Cedex Bio, ViCell, UPLC, plate readers, JMP, Minitab, PowerBI
Responsibilities
Manage PSL study leads and analytics team; serve as SME in technical data analysis and experimental design; review and approve experimental protocols and reports; execute bio-analytical assays and troubleshoot in-process assays; lead process characterization and technology transfer studies; support manufacturing investigations and deviations.
Seniority
Senior, hands-on IC with people management