Principal Research Associate, Analytical Development

Responsibilities

• Manage analytical control strategies to support large-scale process development and optimization for plasmid DNA, cell-free DNA, and enzymes
• Drive analytical deliverables including test method development, optimization, pre-qualification, qualification, and validation
• Set specifications and ensure timely initiation of IPC, release, characterization testing, and stability studies
• Support investigations of out-of-specification (OOS) and out-of-trend (OOT) results in collaboration with SMEs and Quality teams
• Generate high-quality technical documentation to support regulatory submissions and internal communications
• Serve as a subject matter expert in analytical control strategies for DNA and enzymes across cross-functional teams

Requirements

• MS with 5 years of biotech/pharmaceutical industry experience or BS with 8 years of experience in analytical development
• Strong background in chromatographic separation, biophysical characterization, and spectrophotometric techniques
• Proficiency with equipment platforms such as Thermo, Waters, or Agilent
• Experience with data processing software including Chromeleon, ChemStation, or Empower
• Knowledge of industry standards and current FDA and ICH guidelines
• Excellent written and oral communication skills with strong attention to detail

Preferred Qualifications

• Understanding of critical quality attributes and analytical test methods for biologics (plasmid DNA, proteins, enzymes, mRNA, and LNPs)
• Experience with method development and qualification
• Experience with program or project management
• Familiarity with electronic notebooks, LES, LIMS, and Veeva quality management systems

Benefits

• Best-in-class healthcare coverage and voluntary benefit programs
• Holistic well-being resources including fitness, mindfulness, and mental health support
• Family planning benefits including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, sabbatical, and global recharge days
• Savings and investment opportunities

About the Company

Moderna is pioneering the development of a new class of drugs made of messenger RNA (mRNA). We aim to build the leading mRNA technology platform and the infrastructure to reimagine how medicines are created and delivered to patients worldwide.