Role:
Senior analytical scientist providing technical leadership in analytical method lifecycle management within Moderna's biopharma environment, focusing on chemistry-based assays like HPLC/UPLC.
Responsibilities:
lead method transfer, validation, troubleshooting, and continuous improvement; collaborate across Quality Control, Quality Assurance, Regulatory, Manufacturing, and external labs; support investigations and data review; author and review technical documentation; ensure compliance and inspection readiness; and drive process optimization.
Requirements:
Bachelor's (5+ yrs), Master's (3+ yrs), or PhD (0-2 yrs) in Chemistry, Biochemistry, or related field; experience with GMP-regulated pharmaceutical/biotech/biologics/vaccine analytical testing; proficiency with GMP, data integrity, and regulatory standards; strong data analysis and troubleshooting skills; cross-functional team experience.
Preferred:
hands-on expertise in HPLC/UPLC, chromatographic troubleshooting, method validation, and regulatory familiarity with ICH, USP, FDA, EMA guidelines; demonstrated ability to lead investigations and develop scientifically sound solutions; effective communication skills for technical and non-technical stakeholders.
High-value specificsinclude focus on chemistry assays, GMP compliance, late-stage development, and external partnership oversight.
Work setup:not explicitly stated, but involves collaboration with global teams and external labs; no travel specified.
