Senior Research Associate, BMA

Role Summary

Senior Research Associate in Moderna's Bioanalytical and Molecular Assay team, focusing on regulated GLP/GCP bioanalytical LC-MS/MS. Role includes method development, validation, and sample analysis for clinical studies using LC/MS techniques. Requires ability to troubleshoot, collaborate across functions, and maintain high standards in a fast-paced environment.

Responsibilities

• Develop, optimize, validate, and run bioanalytical LC/MS methods for quantitation of various molecules, particularly lipids, biomarkers, and proteins (peptides)
• Draft study plans, bioanalytical methods, and study reports
• Conduct bioanalytical assays following established protocols and SOPs, in compliance with GLP/GCP guidelines
• Coordinate with external CROs on method development, qualifications, and validations; review and approval SOWs, protocols, and reports
• Work closely with colleagues in Clinical Development as well as cross-functional groups
• Provide mass spectrometry support to scientists in Clinical Development, Platform, and other groups
• Stay abreast of literature, government guidelines, internal guidance on clinical trial conduct including GLP, GCP, internal SOPs and regulations and White Papers for pre-clinical and clinical bioanalysis to ensure practices are consistent with regulatory expectations

Qualifications

• Bachelor‚Äôs degree with at least 5+ years laboratory experience or MS with 3+ years of demonstrated hands-on experience with the development and validation of bioanalytical methods using LC-MS
• Hands-on experience with sample preparation/extraction techniques for various analytes from biological matrices such as SPE, LLE, protein precipitation. CRO experience is a plus
• Ability to develop and implement methods for high throughput or (semi-)automated data analysis (e.g. Hamilton/Tecan automation)
• Experience with working with Electronic Lab Notebooks
• Willingness to learn new concepts and challenge boundaries; adaptability to change
• Organization and attention to detail; ability to handle multiple projects in a fast-paced environment
• Strong interpersonal skills with an eagerness to work with and support colleagues in other departments
• Proven ability to develop and work independently and to collaborate cross-functionally to accomplish goals in a timely manner
• Eligibility to work in the US without future sponsorship