Scientist, Analytical Sciences and Technology

The Role

Moderna is seeking an individual to provide technical leadership and execution support for analytical method lifecycle management across commercial and late‑stage development programs. This role will be responsible for method transfer, validation, troubleshooting, investigations, and continuous improvement activities supporting Quality Control laboratories, manufacturing operations, and external testing partners. The candidate will serve as a key technical resource across the analytical network, collaborating with Quality Control, Quality Assurance, Regulatory Affairs, Manufacturing Sciences, and Contract Manufacturing Organizations (CMOs) to ensure robust analytical performance, compliance, and inspection readiness.

The successful candidate will leverage scientific expertise to support product lifecycle management, drive technical solutions, and ensure reliable execution of analytical testing strategies.

• Lead and support analytical method transfers, validations, verifications, and comparability assessments across internal and external laboratories.
• Provide technical expertise for method performance monitoring and lifecycle management activities.
• Evaluate analytical method suitability and identify opportunities for continuous improvement.

• Serve as a subject matter expert for analytical methods and testing processes.
• Support troubleshooting of analytical issues impacting laboratory operations, manufacturing, and product disposition.
• Collaborate cross‑functionally to identify root causes and implement effective corrective actions.

• Support laboratory investigations, out‑of‑specification (OOS), out‑of‑trend (OOT), and atypical result assessments.
• Perform scientific data analysis to identify trends, risks, and opportunities for process improvement.
• Contribute to the development and implementation of CAPAs to address analytical and operational issues.

• Author, review, and approve technical documents including protocols, reports, methods, specifications, and standard operating procedures (SOPs).
• Ensure documentation is accurate, compliant, and inspection‑ready.
• Support regulatory submissions, health authority inspections, and internal audits as required.

• Collaborate with QC laboratories and external testing partners to ensure successful method implementation and execution.
• Provide technical oversight and support for analytical activities conducted at CMOs and contract testing laboratories.
• Support network harmonization efforts and best‑practice sharing across sites.

• Analyze analytical performance metrics and trending data to drive informed decision‑making.
• Support development and implementation of process improvements that enhance efficiency, compliance, and robustness.
• Contribute to digital and data‑driven initiatives supporting analytical operations.

• Bachelor’s degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 5+ years of relevant industry experience.
• Master’s degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 3+ years of relevant industry experience.
• PhD in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 0–2 years of relevant industry experience.
• Experience supporting analytical method transfer, qualification, validation, verification, or lifecycle management activities in a GMP‑regulated pharmaceutical, biotechnology, biologics, or vaccine environment.
• Experience authoring and reviewing technical documents, including protocols, reports, specifications, test methods, investigations, and SOPs.
• Working knowledge of GMP regulations, data integrity principles, and pharmaceutical quality systems.
• Experience supporting laboratory investigations, including OOS, OOT, deviation, or atypical result assessments.
• Demonstrated ability…