The Role:

In this role, you will lead bioassay development strategy for late-stage programs within the Potency Assurance function, ensuring cell-based assays are fit-for-purpose for clinical development, validation, and commercialization.
As a Director, you will operate at the intersection of product biology, analytical development, and quality, translating complex mechanisms of action into robust, scalable, and regulatory-aligned bioassays that enable global filings and commercial supply.
Working 100% onsite in Norwood as a strategic leader without initial direct reports, you will influence across functions while leveraging advanced digital tools and Generative AI to enhance assay strategy, data interpretation, and lifecycle management.

Here's What You'll Do:

• Define and drive potency assay strategy for late-stage programs, aligning with product mechanism of action, CQA frameworks, and regulatory expectations
• Lead development, qualification, validation, and lifecycle management strategies for cell-based bioassays supporting clinical and commercial products
• Ensure bioassays are mechanistically relevant, connecting product biology to assay design, performance, and control strategies
• Provide strategic leadership for CMC bioassay development, supporting IND/BLA submissions and commercial readiness
• Interpret and apply global regulatory guidelines (e.g., ICH, FDA, EMA) to assay development and lifecycle activities
• Support regulatory filings, health authority questions, and interactions related to bioassays
• Partner cross-functionally with Quality, QC, and Analytical Sciences & Technology (AS&T) to enable method transfer, validation, and commercialization
• Drive resolution of bioassay-related challenges, including investigations, deviations, and comparability assessments
• Lead through influence across cross-functional teams, setting priorities aligned with program and organizational goals
• Oversee potency deliverables across programs, translating technical challenges into risks and mitigation strategies

The key Moderna Mindsets you'll need to succeed in the role:

"We behave like owners. The solutions we're building go beyond any job description."

"We act with dynamic range, driving strategy and execution at the same time at every step."

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

• Ph.D. (preferred) with 6gt;=10 years of relevant industry experience, MS with 6gt;=12 years of relevant industry experience, or BS with 6gt;=15 years of relevant industry experience in Biochemistry, Molecular Biology, Cell Biology, Immunology, Biological Engineering, or related field
• Strong experience in bioassay development within a CMC environment, particularly for late-stage (Phase 2/3 or commercial) programs
• This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work.

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

• Preferred experience with bioassay development for RNA and/or LNP-related products
• Demonstrated expertise in cell-based potency assays for vaccine, rare disease, and/or oncology applications including development, qualification, validation, and lifecycle management
• Deep understanding of regulatory expectations and guidelines (e.g. ICH, FDA, EMA) for bioassays supporting clinical and commercial products
• Experience supporting regulatory submissions and health authority interactions
• Proven ability to drive method transfer, validation, and commercialization readiness
• Strong understanding of analytical control strategies, comparability, and assay lifecycle management
• Demonstrated leadership experience managing teams and influencing cross-functional stakeholders
• Excellent communication and strategic thinking skills, with the ability to connect scientific decisions to CMC and business impact

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.

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.

Export Control NoticeThis 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-TR2