Principal Scientist, Analytical Development

About This Role

Serve as the analytical lead for multiple gene therapy and biologics projects, guiding analytical activities from preclinical through commercial phases. This role involves developing, validating, and implementing analytical methods while ensuring compliance with cGMP and regulatory requirements.

Responsibilities

• Lead analytical development and characterization activities for multiple projects with focus on gene therapy and biologic compounds
• Represent Analytical development on cross-functional teams and maintain accountability for analytical deliverables
• Design, plan, and execute activities for analytical development projects to support pre-clinical through commercial activities
• Execute characterization of gene therapy and biologic modalities using high-resolution mass spectrometry, chromatographic separations, and other biophysical methodologies
• Perform laboratory work and/or direct lab personnel within the company and at external vendors
• Ensure safe laboratory practices and perform analytical development and methods optimization
• Create and implement novel concepts and techniques to support analytical activities with Chemical and Product Development
• Support off-site analytical transfers, manufacturing support, and interaction with contractors
• Provide input into CMC regulatory documentation and supporting work
• Contribute to development of policies and department strategies, and build internal and external professional relationships

Requirements

• Expert knowledge and understanding of analytical chemistry, bioanalysis, and bioprocess/formulation development
• Method development, validation, and transfer experience in Analytical Development
• Proficient in characterization of gene therapy and/or biologic compounds using various modern technologies (e.g., high-resolution MS, SEC, CE, SV-AUC, DSC, CD, plate-based assays)
• Experience and expertise with gene therapy and/or biologic compounds, including cell line banks, plasmids, viral vectors, and residual host cell proteins/DNA
• Knowledge of FDA, EMA, WHO, and ICH regulatory requirements
• Comprehensive understanding of cGMP requirements in drug substance and drug product
• Expert knowledge of cross-functional understanding related to drug development

Qualifications

• BS/BA, MS/MA, or PhD in a relevant scientific field
• 4+ years of relevant experience with a PhD, 10+ years with an MS/MA, or 12+ years with a BS/BA.

Skills

* Required skills

Benefits