The opportunity
The Bioassays and Potency Analysis group strives to deliver creative medicines to patients through performance of bioassay, potency and impurities testing activities within a GxP-compliant QC laboratory to support pre-clinical studies and clinical development for biological products manufactured in a GMP production facility. The incumbent should possess a practical understanding of bio-pharmaceutical drug development and GxP requirements as knowledge of local, regional and global regulatory compliance (ICH, GMP, EPA, OSHA, DEA, etc) are integral responsibilities of this position.
Travel Requirements: none
Location: West Chester, PA
RELOCATION ASSISTANCE AND WORK VISA SPONSORSHIP IS NOT AVAILABLE
How you’ll spend your day
Release and stability testing such as cell-based bioassays, ID ELISA, potency ELISA, impurities ELISA (e.g. executing testing, results analysis, peer review of data, etc.)
Method qualification, validation and transfer.
Laboratory investigations (e.g. deviations, Out of Specification, Out of Trend results)
Management of standard operating procedures, work instructions, protocols, reports, and standard practices.
Actively contribute to the maintenance of a compliant, clean, safe working environment (e.g. records, instruments, equipment, materials, reagents, quality systems etc.) in the laboratories by maintaining compliance with applicable ICH, GMP and safety regulations.
Participate in internal and external audits, inspections, regulatory assessments, and filings.
