Director, CMC Writing

The Role

Technical Development is hiring a experienced Director to join the Chemistry, Manufacturing, and Controls (CMC) Writing Center of Excellence to raise the bar for CMC technical narrative across our pipeline. You’ll partner with Process Development, Analytical Development, Manufacturing, Manufacturing Sciences & Technology (MS&T), Quality, and CMC Regulatory, to ensure that data and technical strategy are transformed into crisp and phase-appropriate narrative for clinical and commercial regulatory submissions. In this role, you will coach subject matter experts, build scalable standards for CMC strategic documents, and bring a modern, data-driven approach to how we author, review, and maintain CMC documentation. The ideal candidate for this role would have extensive experience in process or analytical development in support of multiple successful BLA/MAA submissions, with a skill for clear and concise technical writing and passion for employee development.

Here’s What You’ll Do

• Serve as the principal CMC writing consultant, reviewer, and finalizer for high-impact deliverables, including CMC sections for regulatory submissions and responses to information requests.
• Work with subject matter experts (SMEs) to translate complex into clear narratives and well-structured tables and figures, ensuring clarity, accuracy, and regulatory alignment prior to submission.
• Implement quality and efficiency metrics and drive continuous improvement.
• Champion digital/structured authoring techniques and evaluate the role of artificial intelligence (AI) tools in the document lifecycle.
• Orchestrate the lifecycle and communication of key CMC strategy documents and decisions.
• Build and deliver technical writing curricula and hand-on coaching for SMEs and reviewers.
• Provide matrix leadership across teams and programs to drive consistency and upskilling across Technical Development.

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

• BS or MS with 15 to 20+ years of relevant industry experience, or PhD with 10 to 15+ years of relevant experience in CMC technical development (e.g. process or analytical development) and technical writing for regulatory submissions (e.g., INDs, BLAs).
• Extensive experience authoring, reviewing, and developing strategy for CMC sections for regulatory filings.
• Deep working knowledge of current regulatory guidance (e.g. ICH) and their application to CMC and submission strategy.
• Demonstrated ability to translate complex technical data and strategies into clear and compelling narrative aligned with regulator expectations and guidance.

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

• Hands‑on background in Analytical Development (method development) and/or Process Development/MS&T (scale‑up, tech transfer, PPQ) for biologics or nucleic‑acid modalities (e.g., mRNA/LNP).
• A high standard and well-articulated vision of what excellence looks like in CMC technical writing for regulatory submissions and a strong passion to educate and coach authors to
• Fluency with modern tooling (e.g., Veeva Vault, JMP, Spotfire, structured authoring) and comfort exploring AI‑assisted authoring techniques.
• Proven matrix leadership and influence skills across cross‑functional teams.
• Track record building training programs and coaching scientists to write with clarity.

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 $158,000.00 - $284,500.00. 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.

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