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Job: Process Development Specialist III, Medicago USA, Durham, NC

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General Information


Job title: Process Development Specialist III
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Job location: Durham, NC  27713 United States
Requisition code:
Date posted: 02/05/2018
Job category:Process Development
Employment type:Full time
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Job Description

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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.
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Job Requirements

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• 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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