The Role

In this role, you will serve as the Analytical Program Lead (APL) for a family of programs, accountable for all analytical activities required to support regulatory filings (e.g., IND and BLA/MAA) and early post-approval lifecycle activities. You will lead the definition and execution of program-level analytical strategies to enable successful clinical introduction, licensure. and transition to commercial manufacturing.

You will be responsible for driving analytical readiness for clinical and registrational stage programs, including specification setting, analytical control strategy development, and comparability strategy design and execution (e.g., process changes, site transfers, lifecycle evolution), as well as generation of robust data packages to support global submissions. This role requires strong cross-functional leadership and the ability to ensure alignment across development, manufacturing, quality, and regulatory teams.

This is an individual contributor role focused on program delivery, scientific rigor, and regulatory excellence. The role also plays an integral part in authoring and reviewing regulatory sections and responding to RTQs across programs.

Here’s What You’ll Do

• Serve as the Analytical Program Lead for a family of programs, accountable for all analytical activities required to support regulatory filings (e.g., IND and BLA/MAA) and early lifecycle submissions.

• Define and execute integrated analytical strategies, including specifications, analytical control strategy, comparability (process changes, site transfers, lifecycle), and assay lifecycle management.

• Establish commercial specifications, control strategies, and comparability frameworks to enable initial licensure and post-approval changes.

• Ensure analytical readiness for clinical studies and commercial manufacturing, including method qualification/validation, transfer, and control strategy implementation.

• Lead and author analytical sections of regulatory filings (e.g., IND and BLA/MAA) and responses to health authority questions/RTQs, ensuring clarity, consistency, and regulatory defensibility.

• Partner cross-functionally (QC, Regulatory CMC, MS&T, Manufacturing) to deliver robust, compliant, and inspection-ready analytical data packages.

• Identify and mitigate analytical risks, including defining acceptance criteria and justification strategies aligned with global regulatory expectations.

• Mentor team members and contribute to consistent, high-quality execution across programs.

• Additional duties may be assigned from time to time.

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

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 5+ years of relevant industry experience, or M.S./B.S. with 8+ years of experience in analytical development or quality control of biologics or vaccines.

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

• Experience in analytical development for biologics or nucleic acid-based therapeutics, including experience with comparability strategy, study design, and regulatory justification.

• Understanding of analytical control strategy, specification setting, and method lifecycle management for initial licensure.

• Demonstrated experience authoring and reviewing analytical and CMC sections of BLAs/MAAs and responding to health authority queries.

• Knowledge of ICH guidelines, GMP, and global regulatory expectations for late-phase development and commercial readiness.

• Proven ability to translate complex analytical data into clear, concise, and defensible regulatory narratives.

• Experience supporting technology transfer, method validation, and commercial site readiness.

• Cross-functional collaboration skills with Regulatory, Quality, MS&T, and Manufacturing.

• Ability to operate effectively in a fast-paced, matrixed environment with a high degree of accountability.

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Our Working Model

As we build our company, we have always believed that an in-person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations.

Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands-on partnership needed to deliver our mission. 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.

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

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.

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. 

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