Principal Scientist, Analytical Development

Role Summary

This analytical leadership role oversees analytical development for multiple projects, with a focus on gene therapy and biologics, guiding activities supporting drug substance and drug product development from preclinical through commercial phases. The role involves developing, establishing, and validating or qualifying analytical methods to control materials and products, contributing to control strategies, ensuring compliance with cGMP and regulatory requirements, and monitoring progress of assigned tasks.

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; maintain accountability for analytical deliverables and progress on CMC and manufacturing plans.
• Design, plan, and execute activities to support pre-clinical through commercial development goals.
• Characterize gene therapy and biologic modalities using high-resolution mass spectrometry, chromatographic separations, and other biophysical methods.
• Perform laboratory work and/or manage laboratory personnel, including external vendors.
• Ensure safe laboratory practices.
• Conduct analytical development and methods optimization across development stages.
• Create and implement novel concepts and techniques to support analytical activities with Chemical and Product Development.
• Support off-site analytical transfers, manufacturing support, and interactions with contractors.
• Provide input into CMC regulatory documentation and supporting work.
• Leverage literature and regulatory guidance to influence CMC strategies.
• Contribute to policy and department strategy development.
• Build and enhance internal and external professional relationships; support career development and technical growth of team members.
• Present findings at varying levels across the company.
• Other duties as assigned.

Qualifications

• BS/BA and 12+ years of experience, or MS/MA and 10+ years of experience, or PhD or equivalent with 4+ years of relevant experience.
• Expert knowledge of analytical chemistry, bioanalysis, bioprocess understanding, and formulation development.
• Method development, validation, and transfer experience in Analytical Development.
• Proficient in characterization of gene therapy and/or biologic compounds using technologies such as high-resolution MS, SEC, CE (icIEF/CE-SDS), SV-AUC, DSC, CD, and plate-based assays.
• Experience with gene therapy and/or biologic compounds including cell line banks, plasmids, viral vectors, and residual host cell proteins/DNA.
• Excellent interpersonal, oral, and written communication skills with strong laboratory and productivity capabilities.
• Knowledge of FDA, EMA, WHO, and ICH regulatory requirements; understanding of cGMP in drug substance and drug product; cross-functional understanding related to drug development.

Skills

• Analytical method development and validation
• Mass spectrometry, chromatographic separations, and biophysical characterization
• Cross-functional collaboration and project leadership
• Regulatory documentation support and scientific communication

Education

• PhD in a relevant field or equivalent experience (preferred)
• MS/MA or BS/BA in a related discipline (as applicable to the role)