Scientist, Analytical Sciences and Technology

Role: Provide technical leadership and execution support for analytical method lifecycle management in a biopharma setting, focusing on quality control and manufacturing. Responsibilities: Lead method transfer, validation, troubleshooting, and investigations; support continuous improvement activities; author and review technical documentation; collaborate with QC labs, external partners, and regulatory teams to ensure compliance and robust analytical performance; analyze data for trends to drive process improvements. Requirements: Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 5+ years (or Master's with 3+ years, or PhD with 0-2 years) of GMP-regulated pharmaceutical or biologics experience supporting analytical methods; knowledge of GMP regulations, data integrity, and investigative procedures; strong technical troubleshooting and data analysis skills. Preferred: Experience with chromatographic, spectroscopic, or biochemical techniques; regulatory knowledge (ICH, FDA, EMA); experience with external testing labs, method validation, and lifecycle strategies. HighValue: Focus on biologics or vaccine products, late-stage development, or commercial supply; cross-functional collaboration with Quality, Manufacturing, Regulatory, and external testing partners. WorkSetup: Not specified, but involves collaboration across laboratories and external vendors.