Scientist, Analytical Development

Role Summary

Scientist / Manager for Moderna’s Norwood, MA Technology Center to lead the Reference Standard strategy and lifecycle management that underpins analytical activities for mRNA programs. Design and execute acquisition, qualification, re-qualification, change-control, and phase-transition plans to keep RNA, lipid nanoparticle, and drug-product reference standards fit-for-purpose throughout clinical development. Oversee aliquoting, inventory, distribution, and shipments with end-to-end traceability; analyze data to inform decisions; author protocols and regulatory submissions; and promote safety, data integrity, and cross-functional collaboration.

Responsibilities

• Lead the end-to-end Analytical Reference Standard strategy for RNA, lipid nanoparticle and drug product for mRNA programs in clinical development.
• Collaborate with Analytical Development, Process Development, Analytical Tech Operations, Analytical Sciences and Technology, and Quality Control 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 logistics for Reference Standard (aliquoting, storage, inventory, distribution, shipping, disposal) to ensure full compliance and traceability.
• Demonstrate independent scientific judgment in study design, data interpretation, protocols and reports, regulatory filings, and responses to agency queries; present findings to multidisciplinary teams.
• Maintain a safe laboratory work environment and ensure good documentation practices.

Qualifications

• Required: B.S. with 5‚Äì10 years or M.S. with 3‚Äì5 years of relevant industry experience in analytical development, or quality control; GMP analytical-chemistry experience preferred.
• Required: Proven ability to manage projects of significant scope and complexity, meeting deliverables and timelines.
• Required: Hands-on experience in data analysis and statistical evaluation; hands-on experience in analytical method development and analytical reference standard.
• Required: Experience in documentation and authoring regulatory submission documents in pharmaceutical or biotech industries.
• Required: Exceptional organizational, communication, and critical thinking skills; ability to thrive in a collaborative, idea-rich environment.
• Required: Excellent interpersonal and collaborative skills; ability to navigate ambiguity and rapid growth.
• Preferred: Prior hands-on industry experience with analytical development for nanoparticles, RNA, therapeutics, or biologics.
• Note: This position is site-based and not eligible for remote work.

Skills

• Analytical development and quality control
• Reference standard management and lifecycle tracking
• Data analysis and statistics
• Regulatory submissions and correspondence
• Project management and cross-functional collaboration

Education

• B.S. (5‚Äì10 years) or M.S. (3‚Äì5 years) in analytical development, chemistry, or closely related field

Additional Requirements

• Site-based role; in-person work required.