Senior Scientist, HPLC

Position: Senior Scientist, HPLCBioAnalysis, LLC is an agile, non-clinical CRO (Contract Research Organization) that provides answers to the toughest questions with scientifically in-depth analyses. Our customers receive the most rigorous investigations and recommendations possible for gene therapy and other biotherapeutics candidates.We are currently looking for a Senior Scientist to join our fast-growing and dynamic organization.Duties/Responsibilities:Develop HPLC methods in support of characterization and cGMP activities Author SOPs, OOS, CAPAs, Deviations, and all relevant Quality documentation.Author general reports and supporting documentation required by BioAnalysis.Perform HPLC experiments: From sample preparation to data analysis and reporting.Establish residual, aggregation and excipient detection/quantitation workflows for gene therapy programs.Peer and scientific review of cGMP and non-GMP data.Perform routine maintenance, troubleshooting, and calibration of HPLC instruments and detectors to ensure optimal performance and data integrity.Maintain detailed and accurate laboratory records, including experimental procedures, raw data, and analytical reports, in compliance with regulatory and company standards.Work cross-functionally with other scientists, quality teams, and clients to support project needs and meet deadlines.Contribute to the continuous improvement of laboratory workflows, protocols, and procedures to enhance efficiency and data quality.Collect, analyze, and interpret HPLC data, ensuring accuracy, reproducibility, and compliance with quality standards.Required Skills/Qualifications:Ability to work unsupervised.Must be organized and adaptable to a fast-paced environment.Must be able to manage multiple. simultaneous projects and priorities.Must have the desire to learn and master new technologies.Lab experience handling biologics desired.Must be a clear and effective communicator (oral and written).Hands-on experience with HPLC, or related analytical instrumentation.Strong understanding of analytical method development, qualification, and troubleshooting in a regulated environment.Proficiency in data analysis software for HPLC applications (e.g., Empower, or equivalent).Strong problem-solving skills, attention to detail, and ability to work independently or in a team.Excellent written and verbal communication skills for documentation, reporting, and client interaction.Either Analytical Method Development or cGMP validation experience desired.Education and Experience:BA/BS in Biology, Chemistry, or related discipline with experience Master’s or Ph.D. preferred.Three or more years of industry experience in CRO, CDMO, or pharmaceutical industries.Experience in a GLP/GMP environment is a plus.Candidates must be authorized to work in the US. BioAnalysis, LLC is an equal-opportunity employer. We celebrate diversity and encourage applicants of all backgrounds to apply, especially those traditionally underrepresented in STEM.