Supervisor, Bioassay NPI
Core
Oversight and operation of the Bioassay QC NPI laboratory performing Cell-Based Potency Assay (CBPA) and ELISA testing of development and clinical biologics products.
Role type
Senior IC laboratory supervisor (bioassay)
Builds
Development and clinical biologics products
Domain
Biologics manufacturing / Bioassay testing
Required skills
Biological Sciences (BSc+), GMP laboratory operations, bioassay methodology (CBPA, ELISA), biologics manufacturing knowledge, biostatistics, team leadership, regulatory compliance (QA/EHS), staff recruitment, performance management, training and certification, data review, cross-functional collaboration
Preferred skills
Conflict resolution, organizational skills, interpersonal skills, project prioritization
Technologies
None stated
Responsibilities
Schedule and complete release and stability testing for development pipeline products, communicate results to stakeholders, manage ancillary laboratory activities (reagent screening, housekeeping, paperwork), support personnel development and succession planning, coach Analytical Technology Specialists, ensure regulatory compliance, maintain laboratory capacity, review and approve documents, collaborate with Microbiology/Chemistry/Production/QA/Planning
Seniority
Senior, hands-on IC with team leadership
