Note: The job is a remote job and is open to candidates in USA. Moderna is a leading biotechnology company focused on mRNA technology and innovative medicine solutions. They are seeking a Scientist in Analytical Sciences and Technology to provide technical leadership for analytical method lifecycle management and ensure compliance and inspection readiness across various programs.
Responsibilities
- 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 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
Skills
- Bachelor's degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 5+ years of relevant industry experience; OR
- Master's degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 3+ years of relevant industry experience; OR
- 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
- Strong understanding of analytical method validation, transfer, qualification, verification, and lifecycle management principles, including application of risk-based and phase-appropriate strategies
- Hands-on experience with chromatographic, spectroscopic, molecular, lipid-based, vaccine, biologics, or biochemical analytical techniques
- Knowledge of applicable regulatory and compendial expectations, including ICH, USP, FDA, EMA, and other global health authority requirements
- Experience leading or substantially contributing to investigations, CAPAs, deviation management, change controls, or analytical troubleshooting activities
- Experience working with external manufacturing organizations, contract testing laboratories, or other third-party testing partners
- Experience supporting analytical control strategies, method readiness, product lifecycle changes, or regulatory filing activities
- Ability to communicate complex technical topics clearly to cross-functional stakeholders, including Quality, Manufacturing, Regulatory, Technical Development, and senior leadership audiences
- Demonstrated ability to operate effectively in a matrixed, fast-paced, and evolving technical environment
Benefits
- 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
Company Overview