Sr. Scientist I - Extractables & Leachables

Job description

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary: The Senior Scientist I will support Extractables and Leachables (E&L) testing for pharmaceutical products. This role focuses on trace level analysis to identify compounds that may leach from manufacturing components and container closure systems into liquid formulations, supporting patient safety and regulatory compliance. This is a hands on, mass spectrometry driven position emphasizing method development and GMP rigor. On-Site Expectations: - 100% on-site position. - 1st Shift: Monday - Friday, 8:00am - 5:00pm. Responsibilities: - Execute extractables and leachables studies to identify potential migrants from packaging and manufacturing materials - Develop, optimize, and validate chromatography and mass spectrometry based methods for trace analysis - Interpret complex analytical data and support identification of unknown compounds - Generate and maintain GMP compliant documentation, proto...