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Job: Process Development Specialist III, Medicago USA, Durham, NC
Process Development Specialist III
Durham, NC 27713 United States
Under the supervision of Process Development management, the candidate is responsible for execution and assisting in the design of Process Development experiments. Responsibilities involve day-to-day biopharmaceutical experiment execution, documentation, and coordination and process efficiency improvements.
• Able to initiate projects with some supervision.
• Provide help in identifying and developing new processes
• Assist with the design and execution of process scale-up and process optimization experiments under manager’s supervision.
• Assist with the technology transfer from the development group to the manufacturing group as needed.
• Summarize results in development reports and presentations.
• Assist the manufacturing group with SOP, STM and Batch Record writing.
• Assist the manufacturing group with resolution of process deviations and change control.
• Assist with the maintenance and day to day operation of the process development lab
• Support production of critical raw materials, process intermediates and/or Drug Substance
• Minimal travel to company R&I facility in Quebec from time to time as needed.
• Experience with at least one of the following pieces of equipment is required: centrifugation, depth filtration, tangential flow filtration or chromatography.
• Theoretical and practical experience with biological assays like SDS-PAGE, BCA, Picogreen are needed.
• Experience with SRID and HA assay is a plus.
• Knowledge of Design of Experiment is preferred
• Able to collaborate closely with colleagues outside their immediate department to meet critical production timelines
• Able to document activities in scientific/regulatory reports and generate documents and methods to support process development activities
• Some experience in establishing cGMP compliant production processes and writing the supporting documentation is desired
• Previous experience working with plants a plus
• The employee is occasionally required to stand (up to 6 hours a day), walk, reach with hands and arms and stoop, kneel, crouch or crawl
• Ability to lift 30 - 50 pounds and move equipment
• Technical degree with a minimum of 5 years’ experience or University degree with a minimum of 4 years’ experience or equivalent.
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North Carolina Biotechnology Center