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Job: Industrial Process Supervisor, Medicago USA, DURHAM, NC


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General Information

(3697911)

Job title: Industrial Process Supervisor
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Job location: DURHAM, NC  27713 United States
Requisition code:
Date posted: 01/06/2018
Compensation:
Job category:Manufacturing and Production
Employment type:Full time
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Job Description


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Under the supervision of an Industrial Process Manager or Director of Industrial Process, the candidate is responsible for execution of activities for biopharmaceutical production. Responsibilities involve day-to-day biopharmaceutical production, documentation, coordination and process efficiency improvements.

Tasks/Responsibilities:
• Assist with purchasing and commissioning of equipment used in the production process
• Coordinating production/maintenance execution and scheduling to meet business requirements
• Independent process/project leadership
• Supervising a team of process specialists and their day-to-day activities including hiring, work distribution, management of health and safety, and performance evaluations
• Participate/lead design, process scale-up, development of master documentation, process optimization, technology transfer, and process validation activities
• Performs all operations required for production of critical raw materials, process intermediates and/or Drug Substance
• Collaborates with process development group to assure smooth process transition to manufacturing, summarizes production data to support future development efforts
• Support the generation and resolution of process deviations and change controls
• Develop process training curriculum and provide required training
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Job Requirements


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• Experienced in pilot or large scale fermentation, clarification, and/or purification operations
• Able to collaborate closely with colleagues outside their immediate department to meet critical production timelines
• Ability to train, motivate, and lead a team to meet day-to-day and long term objectives
• Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors in a development/production environment
• Able to document activities in scientific/regulatory reports and generate documents and methods to support manufacturing operations
• Experienced in establishing cGMP compliant production systems and writing the supporting documentation
• Provides input and process floor leadership in a fast-paced team environment
• Experience with flexible/disposable single-use systems is a plus
• Occasionally required to stand, for 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

Education/experience:
• Technical degree with a minimum of 9 years’ experience or University degree with a minimum of 7 years’ experience or equivalent. Supervisory experience desired.
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