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 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.  Here’s What You’ll Need (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) 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.  Here’s What You’ll Bring 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 & 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).  Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. 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 The salary range for this role is $167,000.00 - $300,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.   By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.  We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.  If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.  Our Working Model  As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.  Moderna is a smoke-free, alcohol-free, and drug-free work environment.  Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.  Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.  Accommodations We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.  Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.  Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
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