Director, Process Development

ModernaTX•Norwood, MA

4d•Onsite

About The Position

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 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 economics. Support investigations and troubleshooting through integrated upstream–downstream root cause thinking. Deliver on tech 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.

Requirements

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 with demonstrated impact on strain development, bioreactor process scale-up/scale-down, robustness, tech transfer, and manufacturing readiness.
Subject matter expertise in strain engineering and fermentation optimization, including 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 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.
Proven people leadership and ability to lead through ambiguity and fast timelines.
Strong cross-functional influence and communication skills; ability to operate as a technical decision-maker and escalation point.

Nice To Haves

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 & plasmid production in E. coli and/or broader microbial hosts.
Track record implementing 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 knowledge or better across 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 with internal/ external manufacturing partners (governance, tech transfer, troubleshooting, change management).

Responsibilities

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 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 economics.
Support investigations and troubleshooting through integrated upstream–downstream root cause thinking.
Deliver on tech 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.

Benefits

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras

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