Scientist, Analytical Development

ModernaTX • Norwood, MA

12h • $109,200 - $174,600 • Onsite

About The Position

The Role: Moderna is seeking a Scientist / Manager for our Norwood, MA Technology Center to lead the Reference Standard strategy and lifecycle management that underpins analytical activities for our mRNA programs. Partnering with technical and operations teams across Analytical Development, Analytical Tech Operations, Quality Control, Analytical Science & Technology, Process Development, Manufacturing, and Regulatory Affairs, this position will design and execute the acquisition, qualification, re-qualification, change-control, and phase-transition plans that keep RNA, lipid nanoparticle, and drug-product reference standards fit-for-purpose throughout clinical development. Reporting to the Director of Analytical Science, this person will oversee aliquoting, inventory, distribution, and shipments with end-to-end traceability; mine and trend analytical data to inform decisions; author protocols and regulatory submissions; and champion a culture of safety, data integrity, and cross-functional collaboration. Here’s What You’ll Do: Lead the end-to-end Analytical Reference Standard strategy for RNA, lipid nanoparticle and drug product for mRNA programs in clinical development. Work closely with colleagues within Analytical Development, Process Development, Analytical Tech Operations, Analytical Sciences and Technology and Quality Control teams to manage Reference Standard lifecycle activities (acquisition, qualification, requalification/stability, phase transition change/bridging), and drive timelines using project management tools. Review, track and assess Reference Standard data, and document and communicate findings. Oversee all logistic for Reference Standard, such as aliquoting, storage, inventory, distribution, shipping, and disposal activities to ensure full compliance ad traceability. Demonstrate independent scientific judgment to study design, data interpretation, technical protocols and reports, regulatory filings, and responses to agency queries; Clearly present findings to multidisciplinary teams. Maintain a safe laboratory work environment and be accountable for good documentation practices.

Requirements

• B.S. with 5-10 years or MS with 3-5 years of relevant industry experience in analytical development, or quality control, or closely related field.
• GMP analytical-chemistry experience is preferred.
• Proven ability to manage projects of significant scope and complexity, while meeting all deliverables and timelines.
• Hand-on experience in data analysis and statistical evaluation.
• Hand-on experience in analytical method development and analytical reference standard.
• Experience in documentation and authoring regulatory submission documents in pharmaceutical or biotech industries
• Exceptional organizational, communication, and critical thinking skills, and the ability to thrive in an interdependent and idea-rich environment .
• Excellent interpersonal and collaborative skills .
• Ability to navigate through ambiguity and rapid growth and adapt to change.

Nice To Haves

• Previous hands-on industry experience with analytical development for nanoparticles, RNA, therapeutics, or biologics is a plus and preferred

Responsibilities

• Lead the end-to-end Analytical Reference Standard strategy for RNA, lipid nanoparticle and drug product for mRNA programs in clinical development.
• Work closely with colleagues within Analytical Development, Process Development, Analytical Tech Operations, Analytical Sciences and Technology and Quality Control teams to manage Reference Standard lifecycle activities (acquisition, qualification, requalification/stability, phase transition change/bridging), and drive timelines using project management tools.
• Review, track and assess Reference Standard data, and document and communicate findings.
• Oversee all logistic for Reference Standard, such as aliquoting, storage, inventory, distribution, shipping, and disposal activities to ensure full compliance ad traceability.
• Demonstrate independent scientific judgment to study design, data interpretation, technical protocols and reports, regulatory filings, and responses to agency queries; Clearly present findings to multidisciplinary teams.
• Maintain a safe laboratory work environment and be accountable for good documentation practices.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees