Staff Scientist
Core
Lead R&D life cycle management and new/sustaining product projects for biological indicator (BI) products, focusing on microbial fermentation, enzyme purification, and sterilization processes.
Role type
Staff Scientist (R&D & Life Cycle Management)
Builds
Biological indicator products for medical device reprocessing and infection control
Domain
Healthcare sterilization / Microbiology / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbial fermentation process development, Enzyme purification, Product and test method validation, GMP compliance, Statistical analysis (Minitab), Process development and validation, Design changes for marketed products, Technical investigations (NCs/CAPAs), Cross-functional collaboration
Preferred skills
Bacterial endospore production, Terminal sterilization principles, IQ/OQ/PQ processes, FDA QSR and ISO 13485 knowledge, AAMI/ISO standards for biological indicators, Lean/Six Sigma (Green Belt), Analytical method development and transfer
Technologies
Minitab
Responsibilities
Lead liquid culture for microbial fermentation process development and implementation, Collaborate on enzyme purification and activity control studies, Execute product and test method development and validation, Lead R&D and life cycle management activities, Lead design changes for marketed products, Work with manufacturing engineers to integrate biological indicator processes, Lead or support technical investigations and CAPAs, Provide support for new product introduction and change management projects, Prepare and assist with strategic vision or plan, Ensure adherence to compliance standards (ISO, QSR, FDA)
