Role OverviewModerna is seeking an Individual that will 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.
What You Will Do
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.
Why It Might Be a Fit
The successful candidate will leverage scientific expertise to support product lifecycle management, drive technical solutions, and ensure reliable execution of analytical testing strategies.
Requirements
- 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 standard operating procedures (SOPs)
- Working knowledge of GMP regulations, data integrity principles, and pharmaceutical quality systems
- Experience supporting laboratory investigations, including out-of-specification (OOS), out-of-trend (OOT), deviation, or atypical result assessments
- Demonstrated ability to analyze scientific data, identify trends, and apply scientific judgment to solve technical problems
- Experience working effectively in cross-functional teams with Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, and/or external partners
Benefits
- Competitive healthcare
- Voluntary benefit programs
- Holistic approach to well-being
- Fitness, mindfulness, and mental health support
- Family planning benefits
- Generous paid time off
- Savings and investments
- Location-specific perks and extras
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