Six Month Goals

• Optimize NetSuite and implement targeted functionality
• Identify and implement critical business processes needed for clinical trial compliance
• Provide Value Stream Mapping
• Deliver targeted process improvements and specification hardening
• Facilitate design transfer of product changes in scope for clinical trial start
• Produce process validation master plans, PFMEAS, and validation of equipment, methods, and processes needed for clinical trial readiness
• Expand the team to support clinical trial production volumes
• Determine KPI’s and standardize reporting
• Formalize requirements for new consumable manufacturing facility and work with designers to finalize design outputs

How You Will Contribute

• Establish, refine, and execute production plans, including identifying and securing resource requirements to meet organizational needs
• Develop, monitor, and report on effective department performance metrics
• Generate effective design transfer requirements for new product introduction and product changes
• Identify and implement continuous improvement initiatives targeting quality, compliance, safety, efficiency, scaling, and cost; and business process optimization and lean initiatives to eliminate waste and enhance operational control, responsiveness, and flexibility
• Facilitate optimization and guard-banding of critical process parameters
• Manage consumable related BOM’s, resource routings, lot size standards, and variances to maintain accurate costing
• Ensure total productive maintenance of equipment and tools
• Confirm effective equipment, process, and test method validations
• Develop team capabilities in alignment with organizational needs and values
• Assure effective prioritization, investigation, and resolution of findings impacting Consumable Manufacturing identified through audits, non-conformances, corrective/preventative actions, and customer complaint escalations
• Guide the design and implementation of infrastructure improvement initiatives
• Drive departmental capital, headcount, and expense budgeting requirements and maintain accountability to budget integrity and financial performance
• Promote a culture of safety adherence to safety, hazardous waste disposal, and gowning requirements

We’d Love to Hear from You if You

• Have a strong track record of enabling a safety culture
• Apply Engineering Change management best practices appropriately
• Utilize a working knowledge of cost accounting
• Enjoy problem-solving, strategic planning, root cause analysis, and applying data analysis to improving your organization
• Communicate efficiently while still delivering clarity and supporting collaboration – including technical writing
• Value effective people management and developing team members
• Build strong relationships inter- and cross-departmentally

Desired Education & Experience

• A strong understanding of FDA regulations related to IVD medical device development and production – particularly 21 CFR 820, ISO 13485, cleanroom operations and clean formulation of reagents, Lean Manufacturing principles, and Process Failure Mode and Effects Analysis (PFMEA)
• B.S. in a technical or life sciences-related field
• Min 7 years of experience in a biotech or medical device manufacturing environment
• Min 5 years of experience in a management or leadership role
• Lyophilization and/or BSL-2 safety understanding a plus