Responsible for the support of Infectious Disease and Molecular Controls Manufacturing, including planning, scheduling and executing validation. Responsible for process engineering, process improvement, product transfer and scale up of manufacturing. Provides sound, scientific solutions to complex problems related to validations and manufacturing support.
Ability to lead, influence and collaborate with others. Ability to solve problems and address complex issues. Understanding of IVD quality systems requirements under ISO 13485/FDA regulations. Knowledge of experimental design. Excellent communication skills, written and verbal. Proficiency with MS Office and SAP ERP a plus.
BS in biological or physical science or related engineering. Masters degree a plus. 2-5 years experience in Molecular IVD or biological manufacturing. Emphasis in manufacturing engineering, QA, QC or product transfer to manufacturing with validation experience. Infectious disease product experience a plus.Please apply directly at: