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. Moderna is strengthening its presence in Norwood, Massachusetts, a cornerstone of our manufacturing and operational excellence. Our Norwood campus translates mRNA science into scalable impact, supporting the global delivery of our medicines. 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. 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. The role is 100% onsite in Norwood, with no initial direct reports, and requires influencing 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 ≥10 years of relevant industry experience, or MS with ≥12 years of relevant industry experience, or BS with ≥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. Proven 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 Best‑in‑class healthcare coverage, plus voluntary benefit programs. 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. Financial opportunities such as savings and investment programs. Location‑specific perks and extras. Salary range: $167,000.00 – $300,700.00. Additional compensation may include annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility and individual performance. Equal Employment Opportunity Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to race, colour, 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 characteristic protected under applicable law. #J-18808-Ljbffr