Senior Manufacturing Scientist
Core
Support daily production needs of a Reagent protein purification manufacturing work cell, resolving assay failures and maintaining documentation for high-quality finished goods.
Role type
Senior Manufacturing Scientist (Immunoassay/Protein Purification)
Builds
Reagent products for clinical diagnostics
Domain
Life sciences / Clinical diagnostics / Biotechnology
Required skills
Protein purification techniques, Chromatography methods (affinity, ion exchange, size exclusion), Analytical methods (HPLC, UPLC, IEP, IEF, SDS PAGE), Biochemical/immunoassay processes, Data analysis, SOP compliance
Preferred skills
Regulated industry experience (FDA, ISO), Project Management, Manufacturing of biologicals or pharmaceuticals, Validation/verification experience
Technologies
HPLC, UPLC, IEP, IEF, SDS PAGE, Affinity chromatography, Ion exchange chromatography, Size exclusion chromatography
Responsibilities
Investigate and resolve assay failures during in-process/pre/post fill reagent testing, Maintain bills of materials and material specifications, Update/correct SOPs in compliance with quality system standards, Lead multi-department teams to resolve non-conforming issues, Assess manufacturing processes to implement improvements, Solve immunoassay testing and manufacturing issues
Seniority
Senior, hands-on IC
