Analyst, Quality Control

Description

• Perform GMP QC Chemistry methods including HPLC, UPLC, UV, and Particle Analysis via Dynamic Light Scattering
• Execute HPLC (AEX) and NaOH plate reader-based assays to support process stat testing
• Support method transfer projects internally and externally in collaboration with Analytical Sciences & Technology (AS&T) teams
• Execute general lab operational tasks aligned with cGMP, including reagent preparation, equipment maintenance, and good documentation practices
• Provide audit support for both internal and regulatory inspections
• Create, review, and revise SOPs, protocols, and reports aligned with evolving quality standards and compliance frameworks
• Support all stability program operations: perform sample set downs, pulls, inventory checks, labeling, and data entry in LIMS and inventory systems
• Maintain and trend stability data using statistical analysis; produce stability tables, charts, protocols, and final reports
• Troubleshoot assay methods and lab equipment as needed
• Author or contribute to quality system documentation such as investigations, deviations, CAPAs, and change controls
• Assist in the continued optimization of stability and QC workflows, ensuring seamless compliance and operational readiness

Qualifications

• BSc in a relevant scientific discipline (Chemistry preferred) with 5 years Quality Control experience in a cGMP organization with a focus in Analytical Chemistry
• Hands on experience with analytical chemistry techniques including, but not limited to, HPLC, UPLC, particle analysis and plate reader-based assays.
• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred.
• Working experience in a GMP environment.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
• Proven ability to conduct investigations.
• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.
• As part of Moderna’s commitment to workplace health and safety, this role may be subject to pre-employment and periodic medical assessments, in line with relevant legal and operational requirements.