ASU CMC Technical Integration Lead

The Role

The ASU Engine & Global Projects team within Global MS&T is seeking a highly skilled and motivated ASU CMC Technical Integration Lead – COVID/Flu, to drive integrated CMC technical execution for the COVID/Flu Annual Strain Update (ASU). This technical integration role is accountable for connecting Research, Technical Development, MSAT, manufacturing, quality, regulatory, supply, internal site, and CMO inputs into one integrated COVID/Flu ASU technical readiness view, ensuring material readiness, data readiness, evidence readiness, DS-to-DP interface readiness, and site / CMO readiness are technically sound, visible, connected, and decision-ready.

The successful candidate will have the technical judgment to review readiness inputs, pressure-test whether data and evidence are adequate to support ASU decisions, challenge gaps or unsupported assumptions, and translate complex CMC information into clear risks, tradeoffs, options, escalation needs, and governance-ready recommendations. While TD and functional owners retain accountability for technical execution, source data, technical rationale, and approved content, this role owns the end-to-end technical integration required to protect filing- and launch-critical ASU commitments and improve execution year over year.

Here’s What You’ll Do

• Build and manage the integrated COVID/FLU ASU CMC technical execution and readiness plan across TD, MSAT, Manufacturing, Quality, Regulatory, Supply, internal sites, and CMOs.
• Own the COVID/FLU end-to-end CMC technical readiness view by integrating material readiness, data readiness, evidence readiness, DS-to-DP interface readiness, site / CMO readiness, critical milestones, risks, dependencies, decisions, and action owners into one executable plan.
• Review, interpret, and challenge technical readiness inputs from Research, TD, MSAT, Quality, Regulatory CMC, CMC Writing, Manufacturing, Supply, sites, and CMOs to determine whether data, evidence, assumptions, and handoffs are sufficient to support ASU decisions.
• Coordinate Module 3 handoff readiness, RTQ support readiness, documentation traceability, and evidence-readiness needs with Regulatory CMC, CMC Writing, Quality, TD, MSAT, and functional SMEs.
• Drive adoption and training for the automated CTD authoring tool ahead of the next ASU filing season, ensuring ASU teams are prepared to use the tool for Module 3 authoring, source-document linkage, data traceability, human-in-the-loop review, document verification, and timely evidence handoffs.
• Drive cross-functional follow-through on COVID/FLU ASU technical readiness actions, ensuring technical owners, decision needs, due dates, risks, escalation paths, and go / no-go implications are clear.
• Surface COVID/FLU ASU execution tradeoffs early, including technical, data, regulatory, supply, site / CMO, material, DS-to-DP, and launch-readiness implications.
• Partner with the ASU Portfolio & Governance Operations Lead and ASU Strategy BPO / ALPS to ensure technical readiness, risks, milestones, and decisions are accurately reflected in governance inputs, dashboarding, stakeholder communications, and lessons learned.

Primary Deliverables

• COVID/FLU ASU integrated CMC technical execution plan, readiness view, and critical path aligned to the ASU lifecycle timeline.
• COVID/FLU material / data / evidence readiness assessment, including Module 3 handoff, RTQ support readiness, documentation traceability, DS-to-DP interface readiness, and site / CMO readiness status.
• COVID/FLU ASU technical risk, dependency, decision, escalation, and action-owner log that captures technical rationale, open assumptions, readiness gaps, and go / no-go implications.
• Governance-ready COVID/FLU ASU technical tradeoff summaries, options, implications, recommendations, and escalation asks.
• COVID/FLU ASU lessons learned and continuous-improvement recommendations for future ASU cycles and the ASU Engine / ALPS operating interface.

Key Interfaces

• Research, TD, MSAT, Manufacturing, Quality, Regulatory CMC, CMC Writing, Supply, sites, and CMOs for COVID/FLU ASU execution readiness inputs and follow-through.
• DS / DP technical owners, APLs, MSAT Materials, Product Team Lead, DS / DP NPI owners, Site Support, and functional SMEs to integrate technical assumptions and readiness inputs without taking over their functional deliverables.
• ASU Strategy / ALPS for lifecycle-project process, official cadence, dashboarding, stakeholder communication, and governance alignment.

Here’s What You’ll Need (Basic Qualifications)

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or related discipline.
• 8+ years of experience in the biotechnology, pharmaceutical, vaccine, or related industry.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Technical CMC judgment across Research, TD, MSAT, Manufacturing, Quality, Regulatory, Supply, internal sites, and CMOs, with the ability to understand, interpret, and challenge data readiness and evidence sufficiency for ASU decisions.
• Ability to translate strategy and governance direction into integrated technical execution plans with milestones, risks, dependencies, readiness criteria, decisions, owners, and escalation timing.
• Strong DS / DP interface understanding and ability to connect drug substance, drug product, analytical, material, site, CMO, and regulatory-supporting data flows into one CMC readiness position.
• Strong matrix leadership and executive communication: clear technical options, tradeoffs, implications, owners, recommendations, and escalation asks.
• High comfort operating in ambiguity while preserving functional accountabilities and avoiding duplicate process ownership.
• Strong documentation discipline, traceability mindset, technical-review rigor, and continuous-improvement orientation.
• Experience integrating CMC execution across technical development, MSAT, manufacturing, quality, regulatory, supply, site, and CMO interfaces.
• Strong understanding of vaccine / sterile manufacturing CMC readiness, regulatory-supporting data flows, and cross-functional launch or lifecycle execution.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Competitive healthcare, 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 investments to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $142,500.00 - $256,500.00. 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 [email protected]. 

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. #LI-SB2

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