Lead Principal Scientist, Analytical Development

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

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