Biologics Process Development Scientific Lead
Core
Provide technical leadership across biologics process development programs, driving functional alignment, leveraging technology platforms, and ensuring robust, scalable processes for clinical and commercial manufacturing.
Role type
Executive Director-level Biologics Process Development Scientific Lead
Builds
Biologics drug substance processes and platforms
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biologics process development, Upstream cell culture/fermentation, Downstream purification, Process optimization, Scale-up, Technology transfer, Cross-functional leadership, Scientific rigor, Data interpretation, Regulatory documentation
Preferred skills
Platform process strategies, Design of Experiments (DOE), Process characterization, Scale-down modeling, Integrated drug substance development
Technologies
Cell culture, Fermentation, Purification methods, Scale-up models
Responsibilities
Provide scientific and technical leadership across upstream and downstream unit operations; Champion platform-based development strategies to ensure consistency and efficiency; Facilitate knowledge capture and sharing across development programs; Partner with cross-functional stakeholders to align technical strategy and portfolio priorities; Design and oversee process development studies to improve productivity and scalability; Troubleshoot process challenges and recommend data-driven solutions; Review and approve technical reports and documentation for regulatory filings.
Seniority
Executive Director level, strategic leadership with hands-on technical oversight
