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Job: Process Development Engineer, Medicago USA, Durham, NC
Process Development Engineer
Durham, NC 27713 United States
Under the supervision of a Process Development Management, the candidate is responsible for execution and design of Process Development experiments. Responsibilities involve day-to-day biopharmaceutical experiment execution, documentation, and coordination and process efficiency improvements.
• Responsible for the identification and development of new processes
• Design and execute process scale-up and process optimization experiments with minimal supervision.
• Assist with purchasing and commissioning of equipment used in the process development and manufacturing areas
• Collaborates with research Scientists to develop new ideas, techniques and processes.
• Responsible for the Technology Transfer from the Development group to the manufacturing group as needed.
• Summarize results in development reports and write development protocols.
• Assist the manufacturing group with SOP, STM, batch record writing, process deviation and change control documentation
• Process/project leadership or Supervising a team of development scientists and their day-to-day activities
• Data gathering and analysis.
• Support (as required) operations required for production of critical raw materials, process intermediates and/or Drug Substance
• Minimal travel to company R&I facility in Quebec from time to time will be is possible
• Must have knowledge of Design of Experiment
• Experience with protein purification with at least two of the following unit operations is required: centrifugation, tangential flow filtration, depth filtration, enzymatic digestion of plant structural material and chromatography.
• Capable of supervision of a junior team member.
• Able to collaborate closely with colleagues outside their immediate department to meet critical development or production timelines
• Able to clearly and concisely document activities in scientific/regulatory reports and generate documents and methods to support process development and regulatory activities
• Experienced in establishing cGMP compliant production processes and writing the supporting documentation
• Solid statistical background.
• 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 9 years’ experience of University degree with a minimum of 7 years’ experience or equivalent.
• Experience in supervision.
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North Carolina Biotechnology Center