Associate Director, Process Development (Fermentation)

ModernaTX • Norwood, MA

6d • Onsite

About The Position

Moderna is seeking an Associate Director, Process Development to lead upstream/fermentation process development for E. coli-based production of recombinant enzymes, plasmids, and related biological starting materials critical to Moderna’s technology platforms and pipeline programs. This role translates strain, vector, and expression-screening outputs into robust, scalable, and manufacturable processes, with responsibility for microbial fermentation, cell banking strategy, scale-up/scale-down, process characterization, technology transfer, and CMC support. The successful candidate will bring strong technical judgment in E. coli physiology and fermentation engineering and will partner closely with strain and expression screening, downstream purification, analytical development, quality, manufacturing, and CMC teams.

Requirements

• 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.

Nice To Haves

• 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, soft sensors, or process dashboards.
• Working knowledge of downstream operations, including harvest/clarification, cell disruption where relevant, chromatography, UF/DF, impurity clearance, and endotoxin or host-cell impurity control.
• Experience supporting tech transfer, deviation investigations, CAPA, change control, CMC deliverables, and regulatory interactions.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Responsibilities

• 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, backpressure, 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree