BioAnalysis, 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 Principal Scientist to join our fast-growing and dynamic organization.

Duties and 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.
• • Supervise team members as required.
• • 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 and 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.
• • Strong understanding of analytical method development, qualification, and troubleshooting in a regulated environment. Ability to achieve these outcomes.
• • 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 required.

Education and Experience

• • BA/BS in Biology, Chemistry, or related discipline with relevant experience.
• • Master’s or Ph.D. preferred.
• • Four or more years of industry experience in CRO, CDMO, or pharmaceutical industries.
• • Experience in a GLP/GMP environment is expected.

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.