Senior Method Transfer Specialist (Bioassays)
Core
Strategic partner and subject matter expert coordinating and executing large molecule bio-analytical method transfers between R&D and QC sites to support product commercialization and supply continuity.
Role type
Senior IC method transfer specialist (bioassays)
Builds
Robust bio-analytical methods for large molecules (ELISA, PCR, cell culture, virus titration) for manufacturing release
Domain
Commercial pharmaceutical manufacturing (Animal Health)
Required skills
Large molecule bio-analytical method development and validation, GMP production workflows, statistical data analysis (Minitab, Aera), project management, cross-functional coordination, root cause analysis, change control processes
Preferred skills
Spanish language proficiency, Dutch language proficiency, relocation willingness
Technologies
Minitab, Aera, ELISA, PCR, cell culture, virus titration
Responsibilities
Lead and support planning and execution of analytical method transfer plans, conduct risk/gap assessments and prepare transfer documentation, align R&D and QC on acceptance criteria and specifications, provide expert troubleshooting and technical guidance during method development and validation, lead complex multi-site transfer workstreams, perform advanced data analyses and statistical evaluations, contribute to analytical lifecycle maturity initiatives, provide input to departmental strategy regarding method transfers
Seniority
Senior, hands-on IC
