What are the responsibilities and job description for the MSAT Process 1 Engineer position at Akron Bio?
Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team. This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.
Summary
This position is responsible for guiding the execution, resources, business processes and tech transfer for either the upstream or downstream groups within the MS&T department at our Boca Raton BioProducts site. This role will report to the SR MSAT Engineer and work closely with a team of Engineers and Scientists that lead tech transfer projects and will collaborate with internal and external teams to ensure projects are executed efficiently and in a timely manner.
Responsibilities
Technical responsibility for New Product Introductions and Technology Transfers with external partners and internal site.
• Drive NPI portfolio technical robustness from feasibility to launch with support of site and external partners, data review and results interpretation.
• Support technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda.
• Perform investigations, support risk management in relation to products and drive process improvement initiatives
• Author and approve technical protocols and reports, Change Controls, SOPs, Batch Records for site operations
• Represent the department during audits, client meetings and multi-disciplinary meetings with clients and upper management.
• Participate multi-disciplinary projects to improve manufacturing operations, adopt new technologies, increase productivity, reduce cost of goods, streamline practices.
• Ensure that related SOPs describe the process as performed and the control strategy for the discrete manufacturing steps.
• Develop, monitor, and appropriately respond to proactive process monitoring including statistical analysis in JMP.
Requirements
- Bachelor in a science or bioengineering field with a minimum of 5 years industry experience, at least 2 of which include technical operations experience, or Masters/ PhD with 2 years industry experience that include technical operations
- Broad technical exposure in diverse areas including recombinant protein manufacturing, human plasma processing, formulation development, and/or aseptic processing
- Previous experience with technology transfer is required
- Strong GMP experience as well as technical and communication skills: oral/written
- ISO 13485:2016, 21CFR or similar experience
- Experience with JMP/MiniTab or equivalent statistical software
- Project/ Portfolio Management is preferred
- Lean Manufacturing Experience, Green or Black belt preferred
EOE/DFW