Job Description

Principal Scientist position leading analytical separation methods expertise for late-stage and commercial biologic programs at a pharmaceutical company. Responsibilities include method remediation, validation, transfer, and lifecycle management, with cross-functional collaboration across internal and external partners.

Responsibilities

• Lead method remediation, validation, and transfer for separation methods in late-stage and commercial biologic programs
• Conduct troubleshooting and investigations for in-process, release, and stability testing
• Own quality events and analytical activities including change controls, impact assessments, and analytical method-related actions
• Author technical documents including SOPs, validation protocols, reports, and regulatory submissions for biologics programs
• Collaborate with CMOs, CTOs, and external partners on method transfer, product characterization, and regulatory submissions

Requirements

• PhD in Biochemistry, Chemical Engineering, or related field; or Master's with 8+ years relevant experience; or Bachelor's with 10+ years
• Demonstrated expertise in analytical method development, validation, transfer, and lifecycle management for protein-based biologics
• Hands-on experience with chromatographic and electrophoretic separation methods, and impurity characterization for biologics
• Proficiency with GMP, regulatory guidance (ICH, USP/EP/JP), and potency assay requirements for registrational filings
• Strong technical writing skills and ability to collaborate with internal and external stakeholders
• Experience with statistical analysis tools and data trending for analytical methods

Compensation: $138,400 - $207,600 base

Job Tags

Similar Jobs