Seeking a part-time contract/consultant research engineer to support the transition from bench-top manufacturing to large-scale, closed-system production of a cell therapy. A successful candidate has experience with setting up and testing bioreactors and other fluid processing systems. Familiarity with ISO and cGMP standards required, and experience with cell therapy is a plus. The candidate is expected to design, implement and report outcomes from experiments, attend weekly meetings, and contribute to regulatory submissions when needed.
• Execute laboratory experiments in accurate and timely fashion, including obtaining, setting-up and pilot testing a set of bioreactors, separators and agitators. Test each unit for specific outcomes, and then connect the units to create a single production line.
• Develop and write study proposals, collect and analyze data, and write detailed study reports to summarize findings. ?
• Collaborate on laboratory experiments with other R&D personnel.
• Participate in process development meetings.
• Participate in design control and quality by design initiatives.
• Participate in laboratory maintenance activities, such as ordering supplies, calibrating equipment, periodic cleaning, etc.
• Development of Standard Operating Procedures, Preventive Maintenance Instructions, Change Control Documentation, Requirement Specifications, and Validation activities, where applicable.
• Masters degree or PhD preferred in biomedical engineering, chemical engineering, mechanical engineering, biology, molecular biology or related discipline with 2+ years of industry experience.
• Experience with mammalian cell culture preferred, preferably stem/progenitor cells and chondrocytes.
• Familiarity with cGMP regulations (21 CFR Part 210/211, 820 and 1271).
• Knowledge in process and cleaning validations, factory operation, maintenance and system interactions for equipment (product contacted), cleaning and factory utilities is preferred.
• Must be willing to work with human cells/tissue.
• Must have strong verbal, written and interpersonal communication skills