Associate Director, Process Development; Fermentation

Here’s What You’ll Do

• Lead upstream/fermentation process development for
  
  E. coli-based production of recombinant enzymes, plasmids, and related biological materials.
• Manage a team and translate strain, vector, and screening outputs into scalable fermentation processes with clear development strategies, success criteria, and manufacturing-readiness plans.
• Develop and optimize high-cell-density fed‑batch fermentation processes, including media/feed design, induction strategy, and key parameters such as temperature, pH, dissolved oxygen, agitation, aeration, back pressure, and harvest criteria.
• Apply DOE, scale-down models, and data-driven approaches to define operating ranges, improve robustness, reduce variability, and improve titer, yield, productivity, and quality.
• Lead microbial cell banking strategy, including research and development cell bank generation, characterization readiness, storage strategy, traceability, passage history, genetic stability considerations, and fit-for-purpose documentation.
• Partner with Quality, Manufacturing, and internal or external banking partners to ensure cell bank generation and handling align with intended use, process maturity, and CMC expectations.
• Use
  
  E. coli physiology and metabolism to manage growth/production tradeoffs, oxygen limitation, overflow metabolism, acetate formation, redox/energy balance, and carbon flux.
• Develop physiology-aware feeding and induction strategies that improve consistency, product quality, downstream processability, and scale translation.
• Establish and interpret inline, online, and at‑line monitoring approaches, including off-gas analytics, OUR/CER, respiratory quotient, pH/DO behavior, biomass indicators, and other process-state measurements.
• Evaluate and deploy fit-for-purpose PAT tools and partner with automation, digital, and manufacturing teams to support reproducible execution and troubleshooting.
• Partner with downstream purification and analytical development to define upstream-to-downstream interfaces, including harvest timing, clarification strategy, impurity load, endotoxin/host-cell impurity burden, nucleic acid burden, and process economics.
• Lead or support technology transfer, root-cause investigations, process documentation, technical reports, process characterization summaries, and CMC/regulatory sections as needed.
• Serve as a technical leader and mentor for microbial process development, ensuring clear handoffs with the Strain & Expression Screening role and driving scientific rigor, documentation discipline, and fast-cycle learning.

• PhD in Chemical Engineering, Biochemical Engineering, or a related discipline with 5+ years of relevant industry experience; or MS with 10+ years; or BS with 12+ years of relevant industry experience.
• Substantial industry experience developing
  
  E. coli or other microbial upstream processes for recombinant protein, enzyme, plasmid, or related biological production.
• Hands‑on expertise in high-cell-density microbial fermentation, especially fed‑batch
  
  E. coli process development.
• Strong understanding of microbial physiology, metabolism, media/feed development, induction optimization, scale-up/scale-down, and process characterization.
• Experience with microbial cell banking strategy, generation, characterization support, documentation, and interface with process development or manufacturing.
• Experience implementing or interpreting online/inline measurements such as off-gas analytics, OUR/CER, pH/DO trends, biomass indicators, and related process-state measurements.
• Demonstrated ability to lead complex technical projects, influence cross-functional stakeholders, support manufacturing readiness, and communicate clearly through technical writing and presentations.

• Direct experience developing and scaling
  
  E. coli processes for recombinant enzymes and/or plasmids.
• Experience supporting GMP or GMP‑enabling microbial cell banking activities.
• Experience with defined or semi-defined media, advanced feeding strategies, model-based feed control, and PAT tools such as off-gas analytics, capacitance, Raman/NIR,…