- Partner with Fermentation, Purification, and Formulation teams to develop, design, improve, and qualify test new production schemes and production process equipment to support current and future enzyme demand.
- Work with third-party vendors to identify, design, onboard, and qualify new production equipment, including but not limited to bacterial fermentation, cell lysis, clarification centrifuges, buffer exchange, and chromatography
- Partner with the Facilities team to identify the building utility infrastructurerequired to support new equipment operations.
- Drive the operational optimization and integration with MES and SCADA solutions for data acquisition and continuous process control.
- Participate in the seamless transfer of new enzyme expression and purification processes from development into manufacturing.
- Assist in troubleshooting production issues related to yield and quality.
- Update and develop Utility and Process Flow Diagrams, equipment and system P&IDs, and User Requirement Specifications for Production Suites.
- Ensure accuracy of Commissioning Protocols, Execution, and Reports for new and/or renovated space.
- Participate in production process Risk Assessments.
- Demonstrate effective communication and stakeholder management with all levels of the organization, across multiple departments and global sites.
- At least 8-10 years of relevant experiencerequired. Work experience in the biotech, diagnostic, or medical device industry is desired.
- Experience with large-scale bacterial fermentation, clarification, and chromatography highly preferred.
- Experience scaling-up production capacity and automating processes highly desired.
- High-level problem solving and reasoning skills required.
- High-level computer skills are required.
- 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. Experience with batch process simulation and scheduling is desired.
- Experience developing and implementing data communications protocols, networking equipment, PLC’s and other control system architectures compliant with industry standards including ISA-95 a plus.
- B.S./M.S./Ph.D. in Chemical Engineering, Engineering, Bioengineering, Biotechnical Engineering, Industrial or Manufacturing Engineering, with at least 8-10 years of relevant experience in production support and/or process definition and development, design, scale-up, improvement and validation