Scientist, Analytical Development

Responsibilities

• Apply bio separation techniques to support method development, troubleshooting, and process characterization
• Support the establishment, development, and optimization of Analytical Development (AD) and Quality Control (QC) laboratories
• Design, develop, and execute analytical methods including qualification, validation, and technology transfer
• Own method lifecycle management including authoring protocols, reports, and technical documentation
• Perform and interpret analytical assays such as UPLC/HPLC, CE-SDS, and analytical ultracentrifugation (AUC)
• Drive continuous improvement initiatives to enhance assay robustness and data quality
• Collaborate cross-functionally with Process Development, Manufacturing, and Quality teams
• Travel up to 15% to support CDMO projects or business development activities

Requirements

• Master’s degree with 2+ years of industry experience, or Bachelor’s degree with 5+ years, or Ph.D. with relevant experience
• Degree in Chemistry, Biochemistry, Molecular Biology, or related scientific field
• Hands-on experience with UPLC/HPLC, CE-SDS, and/or AUC
• Experience executing assays in a regulated or controlled environment
• Familiarity with Good Documentation Practices, Data Integrity, and ALCOA+
• Strong problem-solving and communication skills

Preferred Qualifications

• Experience in gene and cell therapy
• Experience with MALS and/or CAD detectors
• Experience with Next-Generation Sequencing (NGS)
• Proficiency with statistics, coding, or data management software

About the Company

GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Its subsidiary, ProBio, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies.