Director, Process Development

The Role

Moderna is seeking aDirectorto leadupstreamprocess development with a primary emphasis on E. coli-based production for recombinant enzymes andplasmidscritical to Modernas technology platformsand 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 tointernalmanufacturing.

This role requires deep expertise inphysiology 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.

Heres WhatYoullDo

Set strategy and lead execution

• Own thehoststrainexpressionvector/plasmidand upstreamprocess development strategy for E. coli-expressed enzymes andplasmids

• Translate needs into platform process roadmaps (speed robustness cost scalability quality attributes) and ensure predictable delivery fromstrain developmentthrough tech transferof process.

• Build and develop a high-performing team;establishclear technical standards decision rights and development pathways for scientists and engineers.

Drive best-in-classfermentation 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 andoptimizefed-batch strategies (substrate-limited feeding exponential feeds DO-stat / pH-stat strategies whereappropriate 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

• Leveragestate of the arthost strains and expression vector/plasmid DNA design to deliver on desired processoutcomes ;Engineer strains and vectors foroptimalperformance when

• 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 feedingstrategyand 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; whereappropriate: 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 toanticipateimpacts on yield impurity profiles (including endotoxin/host contaminants and nucleic acid burden) stability and overall process economics.

• Support investigations and troubleshooting through integrated upstreamdownstream root cause thinking.

Deliverontech transfers and CMC excellence

• Lead technology transfer into internal manufacturing ensuring readiness through fit-for-purpose documentation training and success criteria.

• Ensure development is aligned with quality expectations (documentation rigor deviation support CAPA partnership and change control awareness).

• Author and review technical reports and contribute to CMC/regulatory sections as needed.

Heres WhatYoullNeed (Basic Qualifications)

• PhD in Chemical Engineering Biochemical Engineering Microbiology Biotechnology or related discipline (or MS/BS with significant relevant industry experience).

• Significant industry experience(10 years)leadingormicrobialprocess development programs withdemonstratedimpact onstrain developmentbioreactor processscale-up/scale-down robustness tech transfer andmanufacturingreadiness.

• Subject matterexpertisein strain engineering and fermentation optimization including extensive firsthand experience with developing bacterial expression/production processes for enzymes/plasmids.

• Deepexpertisein 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 practical understanding of microbial metabolism as it relates to process performance.

• Experience implementing and interpreting online/inline measurements including off-gas analytics and practical interpretation of OUR/CER for process state and control.

• Provenpeopleleadership and ability to lead through ambiguity and fast timelines.

• Strong cross-functional influence and communication skills; ability tooperateas a technical decision-maker and escalation point.

Heres WhatYoullBring to the Table (Preferred Qualifications)

• Demonstrated hands-on experience and knowledge of fermentation science and biochemical engineering principles theory and practice with a strong understanding of cellular physiology to design new or troubleshoot and improve existing processes

• Direct experience developing and scaling recombinant enzyme& plasmidproduction in E. coli and/or broader microbial hosts.

• Track recordimplementing advanced feeding strategies (exponential feeds substrate-limited regimes) and process state control using respiration metrics and/or soft sensors.

• Experience implementing PAT toolsets for microbial processes (off-gas capacitance model-based estimation).

• Working knowledgeor betteracross downstream operations sufficient to enable effective partnership (harvest/clarification approaches cell disruption concepts where relevant chromatography basics UF/DF concepts impurity control strategies).

• Experience supporting CMC deliverables and regulatory interactions (process descriptions development rationales characterization summaries).

• Experience withinternal/external manufacturing partners (governance tech transfer troubleshooting change management).