Director, Process Development

The Role Moderna is seeking a Director to lead upstream process development with a primary emphasis on E. coli-based production for recombinant enzymes and plasmids critical to Moderna’s technology platforms and pipeline programs . This leader will set technical strategy and drive execution across strain and expression strategy enablement, upstream fermentation process development, scale-up/scale-down, process characterization, and technology transfer to internal manufacturing. This role requires deep expertise in E.coli physiology and fermentation engineering, including fed-batch strategies, media/feed development, inline measurements/PAT, and oxygen transfer/respiration metrics (OUR/CER), with the ability to partner effectively across downstream purification, analytics, quality, and manufacturing to deliver robust, scalable, and compliant processes. Here’s What You’ll Do Set strategy and lead execution Own the host strain, expression vector /plasmid and upstream process development strategy for E. coli-expressed enzymes and plasmids Translate needs into platform process roadmaps (speed, robustness, cost, scalability, quality attributes) and ensure predictable delivery from strain development through tech transfer of process . Build and develop a high-performing team; establish clear technical standards, decision rights, and development pathways for scientists and engineers. Drive best-in-class E.coli fermentation development Lead upstream development for high-cell-density microbial fermentation (especially E. coli fed-batch) including media and feed design and development (defined/semi-defined media, carbon/nitrogen strategies, trace elements, antifoam, osmolality management). Develop and optimize fed-batch strategies (substrate-limited feeding, exponential feeds, DO-stat / pH-stat strategies where appropriate , induction timing/intensity). Optimize key process parameters (temperature shifts, pH, DO, agitation/aeration, backpressure, antifoam, bolus vs continuous feeding). Apply DOE and data-driven development to define robust operating spaces, reduce variability, and improve titer, yield, and product quality. Bring microbial physiology and metabolism into the control strategy Leverage state of the art host strains and expression vector/plasmid DNA design to deliver on desired process outcomes ; Engineer strains and vectors for optimal performance when required Use strong understanding of E. coli metabolism to proactively manage oxygen limitation risk, overflow metabolism (e.g., acetate formation), redox/energy balance, carbon flux, and growth/production tradeoffs. Define and implement physiology-aware control strategies that improve consistency and scale translation, linking feeding strategy and respiration to byproduct formation and quality outcomes. Make inline monitoring and cell health measurement a core capability Establish and standardize inline/at-line monitoring approaches and dashboards, including off-gas analysis and interpretation of OUR/CER and RQ trends for process state awareness. Define and track cell health indicators (e.g., growth rate control, stress-response proxies where measurable, morphology/aggregation indicators, viability where relevant). Deploy fit-for-purpose inline/online sensors and PAT tools (pH/DO; where appropriate : capacitance/biomass, Raman/NIR, soft sensors/model-based estimators). Drive alignment of PAT and automation with manufacturing systems to enable reproducible execution and rapid troubleshooting. Partner effectively across downstream processing Partner with downstream purification and analytical development to define upstream-to-downstream interfaces (harvest timing/criteria, clarification strategy, impurity load management). Demonstrate sufficient downstream awareness to anticipate impacts on yield, impurity profiles (including endotoxin/host contaminants and nucleic acid burden), stability, and overall process eco ... (truncated, view full listing at source)