Director, Process Development

Set strategy and lead execution for host strain, expression vector/plasmid, and upstream process development.,Translate needs into platform process roadmaps and ensure predictable delivery from strain development through tech transfer.,Build and develop a high-performing team, establishing technical standards and development pathways.,Lead upstream development for high-cell-density microbial fermentation, including media and feed design/development.,Optimize fed-batch strategies and key process parameters.,Apply DOE and data-driven development to define robust operating spaces.,Leverage host strains and expression vector/plasmid DNA design for desired process outcomes.,Use understanding of E. coli metabolism to manage oxygen limitation risk, overflow metabolism, redox/energy balance, carbon flux, and growth/production tradeoffs.,Define and implement physiology-aware control strategies.,Establish and standardize inline/at-line monitoring approaches and dashboards.,Define and track cell health indicators.,Deploy fit-for-purpose inline/online sensors and PAT tools.,Drive alignment of PAT and automation with manufacturing systems.,Partner with downstream purification and analytical development to define upstream-to-downstream interfaces.,Support investigations and troubleshooting through integrated upstream–downstream root cause thinking.,Lead technology transfer into internal manufacturing.,Ensure development is aligned with quality expectations and contribute to CMC/regulatory sections.

PhD in Chemical Engineering, Biochemical Engineering, Microbiology, Biotechnology, or related discipline (or MS/BS with significant relevant industry experience).,Significant industry experience (10+ years) leading E.coli or microbial process development programs.,Subject matter expertise in strain engineering and fermentation optimization.,Extensive firsthand experience with developing bacterial expression/production processes for enzymes/plasmids.,Deep expertise in E. coli fermentation, including high-cell-density fed-batch development and execution.,Demonstrated strength in media and feed design and control of nutrient/trace element strategies.,Strong understanding of fermentation physiology and microbial metabolism.,Experience implementing and interpreting online/inline measurements including off-gas analytics.,Proven people leadership and ability to lead through ambiguity and fast timelines.,Strong cross-functional influence and communication skills.,Demonstrated hands-on experience and knowledge of fermentation science and biochemical engineering principles, theory, and practice.,Direct experience developing and scaling recombinant enzyme & plasmid production in E. coli and/or broader microbial hosts (preferred).,Track record implementing advanced feeding strategies and process state control using respiration metrics and/or soft sensors (preferred).,Experience implementing PAT toolsets for microbial processes (off-gas, capacitance, model-based estimation) (preferred).,Working knowledge or better across downstream operations (preferred).,Experience supporting CMC deliverables and regulatory interactions (preferred).,Experience with internal/external manufacturing partners (preferred).

PhD in Chemical Engineering, Biochemical Engineering, Microbiology, Biotechnology, or related discipline; or MS/BS with significant relevant industry experience

Must be able to access export-controlled information in accordance with U.S. law.,Only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position.