Principal Scientist I

Job Description

• Lead the development, qualification, validation, transfer, and lifecycle management of analytical methods supporting viral vector process development, GMP manufacturing, release, characterization, and stability testing.
• Serve as the technical subject matter expert (SME) for biophysical characterization and analytical separation techniques, including HPLC, CE, DLS, UV/Vis, AUC, light scattering, and other orthogonal methods used to characterize viral vectors.
• Design and execute complex technical studies to support method optimization, comparability assessments, process changes, product characterization, and investigation activities.
• Provide scientific leadership for method troubleshooting, lifecycle management, and continuous improvement to ensure robust, reliable, and regulatory-compliant analytical methods.
• Author and review protocols, method qualification and validation reports, SOPs, test methods, technical reports, investigations, CAPAs, change controls, and scientific justifications in accordance with cGMP requirements.
• Analyze and interpret complex analytical data, identify trends, perform root cause analysis, and provide scientifically sound recommendations to resolve technical and quality issues.
• Serve as the technical lead for analytical investigations, including deviations, OOS/OOT, assay performance issues, and method-related quality events.
• Collaborate with Analytical Development, Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, Program Management, and clients to support technology transfer, analytical strategy, and successful execution of viral vector programs.
• Mentor scientists and laboratory personnel by providing technical guidance, scientific expertise, and training on analytical methodologies and GMP expectations without direct supervisory responsibility.
• Support regulatory inspections, client audits, and internal audits by serving as the technical expert for QC biophysical characterization methods and laboratory operations.
• Drive innovation and continuous improvement initiatives to enhance assay robustness, laboratory efficiency, data integrity, and operational excellence.
• Ensure compliance with cGMP, ICH, FDA, EMA, and applicable regulatory requirements while maintaining a state of inspection readiness.