Principal Research Associate, Analytical Development

Key Responsibilities

• Proactively mitigate risks related to method development and validation per ICH Q2 and Q14
• Troubleshoot out-of-expectation results
• Articulate continuous improvement opportunities related to method transfer and routine operations
• Ensure robust method development for clinical-stage qualification and commercial validation-readiness
• Serve as a liaison between Method Development, AST, ATO, and QC, ensuring alignment on analytical method expectations, readiness, and performance
• Represent Analytical Development in cross-functional forums with AS&T and QC
• Ensure methods are designed to meet appropriate technical, operational, and regulatory requirements before qualification or validation
• Serve as subject matter expert for investigations and performance issues across development and QC environments, identifying root causes, supporting hypothesis tests, and implementing solutions
• Influence method development, assay optimization and continuous improvement efforts based on operational feedback, robustness requirements, and lifecycle needs
• Collaborate with Quality and AST teams to support deviation investigations, CAPAs, and change controls related to analytical methods
• Analyze and interpret complex datasets to inform performance, variability, and comparability
• Author and review technical documentation including protocols, reports, method lifecycle documents

• MS with 5 years or BS with 8 years of biotech or pharmaceutical industry experience in analytical development
• Strong hands-on experience with analytical methods, such as HPLC, Absorption, and Molecular Biology assays
• Demonstrated experience with analytical method transfer to QC or external laboratories
• Proven ability to troubleshoot complex assay issues and lead investigations in a GMP or late-stage development environment
• Understanding of CQA frameworks, assay lifecycle management, and regulatory expectations
• Experience working cross-functionally with Quality, QC, and/or manufacturing organizations
• Strong analytical thinking and ability to interpret data to drive decisions and improvements
• Excellent communication skills with the ability to translate technical concepts across functions
• Ability to manage multiple priorities in a fast-paced, highly collaborative environment
• Self-motivated, proactive, and comfortable operating with a high degree of ownership

This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work. At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Competitive healthcare, 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 investments to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $89,900.00 - $. 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…