Principal Scientist

Germer International - Pharmaceutical Recruiting; Malvern (Chester County); On-site; USD 150,000 - 190,000; Full time

Job summary

Germer International is seeking a Principal Scientist to provide technical leadership within Analytical Development for viral vector programs in the United States. The successful candidate will guide analytical strategy, mentor junior scientists, and collaborate cross-functionally across Manufacturing, Quality, and Regulatory teams.

Responsibilities include leading method development, qualification, validation, transfer, lifecycle management, and ensuring regulatory-compliant analytics; act as

Qualifications

• Experience leading analytical development for viral vector programs (development, qualification, validation, transfer).
• Strong cGMP analytical development knowledge and regulatory familiarity.
• Expertise in biophysical characterization and orthogonal analytical methods.

Responsibilities

• Lead development, qualification, validation, transfer, and lifecycle management of analytical methods for viral vector process development and GMP manufacturing.
• Serve as SME for biophysical characterization and analytical separation techniques (HPLC, CE, DLS, UV/Vis, AUC).
• Design and execute complex studies to support method optimization, comparability, process changes, and product characterization.
• Provide scientific leadership for method troubleshooting, lifecycle management, and continuous improvement of analytical methods.
• Author/review protocols, qualification/validation reports, SOPs, test methods, investigations, CAPAs, change controls, and scientific justifications per cGMP.

Skills

Analytical leadership

Biophysical characterization

Method development & validation

Cross-functional collaboration

Data interpretation & troubleshooting

Tools

HPLC

CE

DLS

UV/Vis

AUC

Job description

Our client is seeking a Principal Scientist to provide technical leadership within Analytical Development. The successful candidate will lead analytical strategy, mentor junior scientists, and collaborate cross-functionally.

Key Responsibilities

• 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.