Scientist, Analytical Development

Responsibilities

• Apply knowledge of 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 to enable both Non-GMP and GMP testing
• Design, develop, and execute analytical methods, including method development, method qualification/validation, technology transfer, and product testing
• Own method lifecycle management activities, including authoring and reviewing protocols, reports, and technical documentation
• Perform and interpret a broad range of analytical assays, including but not limited to UPLC/HPLC, CE-SDS, and analytical ultracentrifugation (AUC)
• Drive continuous improvement initiatives across AD and QC, identifying opportunities to enhance assay robustness, efficiency, and data quality
• Analyze complex datasets and effectively communicate results, observations, and recommendations to internal and external stakeholders
• Collaborate cross-functionally with Process Development, Manufacturing, and Quality teams to support product and process advancement
• Perform other duties as assigned based on business needs

Qualifications

• Master’s degree with 2+ years of relevant 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; experience in gene and cell therapy is a plus
• Hands-on experience with analytical techniques such as UPLC/HPLC, CE-SDS and/or AUC; experience working with MALS and/or CAD detectors is a plus
• Experience executing assays in accordance with Standard Operating Procedures and protocols in a regulated or controlled environment
• Strong problem-solving skills with the ability to work independently and collaboratively in a fast-paced environment
• Familiar with principles of Good Documentation Practices, Data Integrity, and ALCOA+
• Strong interpersonal, verbal, and written communication skills
• Experience with Next-Generation Sequencing (NGS) is a plus
• Experience with Microsoft Office tools
• Experience with statistics, coding, programming, troubleshooting, and/or data management software is a plus

Pay

Pay range is estimated between $80k - $110k based on skill set and experience.