Principal Research Associate

Description

• Lead formulation, fill/finish, visual inspection, packaging, and related process validation and tech transfer activities.
• Ensure manufacturing alignment with mRNA/LNP platform standards, author and review cGMP documentation.
• Perform risk assessments, generate SOPs, and establish training programs.
• Monitor key performance indicators to identify and improve inefficiencies.
• Support operational metrics, departmental budgets, and site planning.
• Investigate complex manufacturing issues with cross-functional teams.
• Act as technical expert for audits and inspections.
• Collaborate with global sites on data sharing and best practices.
• Integrate Lean and Six Sigma principles for continuous improvement.
• Execute technical support for media fills, cleaning verifications, and material qualifications.
• Strict adherence to Good Documentation Practices and Data Integrity.
• Completing training per assigned learning plans and requalification schedules.
• Maintaining deep expertise in quality systems, cGMP, and industry standards.
• Performing additional duties as assigned, including exploring opportunities for integration of Generative AI tools to streamline validation and investigation processes.
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Qualifications

• Education: Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
• Experience: A minimum of 3-5 years of experience in the biotech or pharmaceutical industry, with a focus on sterile manufacturing operations.
• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.