BS/BA or Associates Degree in biological sciences, chemical sciences, engineering or equivalent technical discipline. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
• Minimum of 10 years experience in the Pharmaceutical or Biotechnology industry Knowledge and experience in a production area (e.g. cell culture, microbial fermentation, buffer prep, media prep, purification, etc.).
• At least 3 years of manufacturing supervisory experience or similar leadership role (e.g. direct supervision, project leadership, etc.) in industry is required.
• Knowledge and experience in large scale column chromatography, Viral Filtration and UF/DF with extensive experience working on Unicorn and Delta V controls.
• Clear understanding of the control systems used to run processes in modern large scale Biopharmaceutical plants.
• Strong verbal and written communication skills which emphasize teamwork and a strong quality orientation.
• Strong team player with demonstrated ability to lead and motivate a diverse team.
• Demonstrated ability to solve complex technical problems.
• Experience with systems such as SAP/MERP and Qumas is a plus
• Strong quality/compliance orientation and track record. Excellent interpersonal and leadership skills. Strong influence and relationship building skills with an emphasis on teamwork. Comprehensive understanding of Lean/Six Sigma (OE) principles and their application.
Supervises daily biopharm manufacturing operations, a market entry and commercial manufacturing facility that produces protein biopharmaceuticals for clinical and commercial purposes. Provides first line supervision to Manufacturing Associates, who operate microbial fermentation or cell culture equipment, prepare media and solutions, conduct chromatographic separations, perform filtration & concentration operations, prepare buffers and solutions, and perform related administrative duties. Serves as a leader outside of their immediate role in regards to process and system optimization, driving continuous improvement, and participating in cross functional and cross business collaboration and teamwork.
• Provides first-line supervision on day, swing or night shift, to a staff of Manufacturing Associates who conduct: microbial fermentation, cell culture or purification unit operations including overseeing preparation of media and buffers, seed lab operations, large scale microbial fermentation and/or cell culture, harvest and recovery operations, chromatographic processing, filtration and concentration operations, and the ordering of raw materials and components from the warehouse. Production Supervisors are expected to have the capability to perform formentioned activities alongside Manufacturing Associates.
• Perform duties in a compliant manner and behave in accordance with site SOP's, GSK EHS standards and guidelines and relevant legal requirements and ensure that their team do the same.
• Assures that the preparation of bulk biopharmaceutical intermediates meets all quality standards for cGMP, GSK and any other applicable regulatory agency.
• Supports successful implementation of new products and processes into the facility, including all appropriate equipment and area changeover activities.
• Develops Manufacturing Associate work assignments to meet production schedules and to assure that resources are used efficiently and that product delivery targets are met.
• Accountable for Manufacturing Associate development and/or performance management though activities such as assignments and associated technical training programs.
• Initiates/support/lead cross functional and cross business planning, learning, collaboration and teamwork to deliver high quality results.
• Lead and implement continuous improvement and operational excellence methods and tools to improve the overall efficiencies of production operations.
• Demonstrated higher level of leadership capability by optimizing manufacturing and business process improvements and the capacity to stand in for the production manager.
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