Director, Analytical Development

The Role

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

Our Norwood campus in Massachusetts translates mRNA science into scalable impact, supporting the global delivery of our medicines. 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.

Key Responsibilities

• 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.

Basic Qualifications

• Ph.D. (preferred) with ≥10 years of relevant industry experience, MS with ≥12 years, or BS with ≥15 years in Biochemistry, Molecular Biology, Cell Biology, Immunology, Biological Engineering, or a 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 and requires full‑time presence on Moderna’s Norwood site; remote work is not eligible.

Preferred Qualifications

• 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

• Salary range: $167,000.00 – $300,700.00, depending on competencies, education, qualifications, experience, and business needs.
• Potential eligibility for annual discretionary bonus, other incentive compensation, or equity award, subject to company plan and performance.
• Best‑in‑class healthcare coverage and voluntary benefit programs.
• 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.
• Location‑specific perks and extras.

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 an E‑Verify Employer in the United States.

Export Control Notice

This position may involve access to technology or data subject to U.S. export control laws, including the EAR. Employment is contingent upon the applicant’s ability to access export‑controlled information in accordance with U.S. law. Only U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position; Moderna is unable to sponsor non‑U.S. persons for an export control license.

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