• Participate in production process definition and improvement, design, development, and quality test activities in the making of consumable products or support of processes/equipment used to determine genetic variation in multiple species of organisms.
• Troubleshoot production line issues and customer complaints related to yield, quality, and throughput and implement the appropriate robust containments and corrective actions on identification of root cause.
• Construct and execute controlled experiments (including DOE's) to optimize processes, address yield and quality issues, and drive implementation of solutions in a production environment to meet production goals.
• Transfer technology, Mfg and QC processes, products from Development into a regulated manufacturing environment. Represent Operations needs on those Development teams.
• Analyze process test results, issue reports, and make technical recommendations.
• Lead teams in documenting, validating and implementing change.
• Design, develop, test, and implement changes to increase throughput and yield, and/or reduce costs.
• Work cross functionally with R&D, Manufacturing, Regulatory, and Quality to develop processes for new products and improve processes of existing products.
• Define technical requirements and write procedures for Production to process product.
• Define and drive execution of validation plans and protocols.
• Work experience in the biotech, diagnostic, pharmaceutical, or medical device industry is required.
• High level problem solving and reasoning skills required.
• Experience expanding production capacity and automating processes is desired.
• Experience with high volume production in a high-tech consumables industry is highly desired.
• Experience with liquid handling and filling technologies preferred.
• Experience with fluorescence imaging technologies preferred.
• Experience with chemical processes (preferably organic) preferred.
• Experienceapplying statistics, Statistical Process Control, and DOE techniques is a plus.
• High level computer skills are required. Intermediate level programming knowledge is strongly desired. Experience with large data sets a plus.
• Experience with product development processes and project management is desired.
• Good interdepartmental communication skills and documentation skills are required.
• Demonstrated ability to accomplish goals while working across departments is required.
• B.S./M.S./ PhD in Engineering, Bioengineering, Biotechnical Engineering, Industrial or Manufacturing Engineering, or MS/PhD in Materials Science or Physical Chemistry, with at least 5 years of relevant experience in production support and/or process definition and development, design, scale-up, improvement, and validation.