Staff Scientist

POSITION SUMMARY The Staff Scientist is responsible for leading validations for process improvements for manufacturing. The individual shall also be a subject matter expert that will provide support of current and new products in regards to manufacturing and QC related issues. Leader for other departmental or interdepartmental projects, which may require significant planning, testing and documentation to accomplish given task at the St. Louis site. PRIMARY DUTIES Manage projects related to investigating failures in current product production or testing processes. Validate corrective actions and monitor the implementation of preventive actions and process improvements resulting from these failure investigations. Manage projects related to investigating failures in current product production, vendor issues or testing processes. Validate corrective actions and monitor the implementation of preventive actions and process improvements resulting from these failure investigations. Participate in Manufacturing Verification activities for new development rounds. This will include involvement with Design documentation, attending development meetings, determining CQA/CPP for manufacturing processes, and developing testing plans and protocols to determine manufacturability of all newly developed tests. Lead the implementation of successful corrective actions that address process-related issues and corrective actions related to customer complaints. Provide technical expertise to projects related to scaling-up and/or automating production processes in order to meet market demands and drive down the cost of goods sold (CGS). Additional duties include conducting CAPA investigations, and resolving customer complaint investigations. Serve as an SME for customer complaint investigaitons, audits and troubleshooting. Authors and presents technical reports as needed, maintains a laboratory notebook, author internal protocols and SOPs Detect the root cause of manufacturing issues in a timely manner could lead to scrap lots of packaged finished products Manage or lead projects for cost improvements, and process improvements could lead to additional costs or potential scrap KNOWLEDGE, EXPERIENCE & SKILLS B.S in Microbiology or biology. Medical Technology training. MS or PhD degree (desired) Minimum of 5+ years experience as a clinical microbiologist or 10 years working a clincical microbiology setting. Expert understanding of Vitek II systems in a clinical setting. Strong PC skills (Word, Excel, Access, etc.). Knowledge of ISO 9001 and Quality System Regulation. Working knowledge of utilizing statistical software packages (ex minitab, SigmaStat) Familiarity with a GMP production environment, procedures and processes Strong Organizational skills, decision making, communication, teamwork, and troubleshooting skills Statistics Knowledge LEAN manufacturing experience Six Sigma process knowledge and working experience of GMP, GLP and GDP's. Knowledge and work experience dealing with regulatory agency (e.g., FDA and ISO) requirements preferred.