Moderna 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 with a focus on chemistry-based analytical methods.

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.

Here's What You’ll Do

• Lead and support chemistry-focused analytical method transfers, validations, verifications, and comparability assessments across internal and external laboratories, with emphasis on HPLC/UPLC, compendial methods, and other chemistry-based analytical techniques.

• Provide technical expertise for chemistry and compendialmethod performance monitoring, troubleshooting, and lifecycle management activities.

• Evaluate chemistry analytical method suitability and identify opportunities for continuous improvement.

Technical Support & Troubleshooting

• Serve as a subject matter expert for chemistry-based analytical methods andinstrumentation, with particular emphasis on HPLC/UPLC and chromatographic techniques, and compendial testing. 

• Lead and support troubleshooting of analytical issues impacting laboratory operations, manufacturing, and product disposition.

• Collaborate cross-functionally to identify root causes and implement effective corrective actions.

Investigations & Data Review

• 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.

Documentation & Compliance

• 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.

QC Network & External Partner Support

• 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.

Data Trending & Continuous Improvement

• 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.

• Support assessment and implementation of new or revised compendial requirements, including USP and other applicable global pharmacopeial requirements, and evaluate potential impacts to analytical methods, specifications, and testing strategies

• Contribute to digital and data-driven initiatives supporting analytical operations.

Here’s What You’ll Need (Basic Qualifications)

• 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.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Strong hands-on analytical chemistry experience, with demonstrated technical proficiency in HPLC/UPLC and chromatographic method execution, troubleshooting, and data interpretation; experience with additional analytical techniques and compendial methods is preferred.

• Demonstrated ability to independently troubleshoot analytical methods and instrumentation, evaluate unexpected or atypical results, develop scientifically sound hypotheses, and drive technical issues through resolution.

• Strong understanding of analytical method validation, transfer, qualification, verification, and lifecycle management principles, including application of risk-based and phase-appropriate strategies.

• 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.

• Demonstrated technical ownership and independent problem-solving, with the ability to design and execute experiments, interpret complex analytical data, draw scientifically supported conclusions, and recommend next steps.

• Experience supporting analytical control strategies, method readiness, product lifecycle changes, regulatory filing activities, or commercial manufacturing support.

• Ability to communicate complex technical topics clearly to cross-functional stakeholders, including Quality, Manufacturing, Regulatory, Technical Development, and senior leadership audiences.

• Demonstrated ability to prioritize and independently drive technical work in a fast-paced, matrixed environment while collaborating effectively across functions.

Competency

• Scientific problem solving and critical thinking

• Technical leadership and collaboration

• Strong data analysis and interpretation skills

• Effective communication and stakeholder management

• Attention to detail and commitment to quality

• Ability to manage multiple priorities in a fast-paced environment