Scientist, Analytical Sciences and Technology, Chemistry

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* The Role:

** 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 compendial method 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 and instrumentation, 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,…