Supervisor of Downstream Operations

Cranbury, NJ

Post Date: 10/10/2017 Job ID: 7777 Industry: Industry

SUMMARY

The Supervisor, Downstream Operations, will execute and supervise downstream manufacturing operations. The Supervisor, Downstream Operations, will be required to execute and supervise cGMP operations within the Biologics Manufacturing Center.



RESPONSIBILITIES

  • This position will work diligently to meet scheduled timelines, and will work as required to meet production schedule. Weekend, holiday and shift work will be required based on manufacturing schedule as determined by Area Management.



  • Performance and oversight of Downstream cGMP Operations in accordance with Standard Operating Procedures (SOP s); Master Batch Records (MBR s); Equipment Qualification Protocols; and other applicable instructional documentation.



  • Communicates status of operations, troubleshoots process issues, and remedies safety & maintenance issues with Area Management.



  • Provides review of executed documentation for completeness and accuracy and works with Quality Assurance to reconcile comments.



  • Participate in starting up facility and process equipment.



  • Reviews, revises and authors SOPs, Deviations and Change Controls as directed by area management.



  • Innovate technologies that embrace QRM, continuous improvement, reduce manufacturing costs and increase manufacturing efficiency



  • Ensures that all production equipment is functioning properly and production processes meet documented quality standards.



  • Follow all company best practices to minimize cost and meet budgetary requirements.



  • Management team may assign other responsibilities as required.



  • Mentor a staff of up to six (6) direct reports.





QUALIFICATIONS

  • B.S. Life Sciences or equivalent



  • 6 + years progressive industry experience within a downstream biologics drug substance manufacturing environment.



  • Superior ability in cGMP bioprocess operations, particularly downstream processes, of mammalian expressed glycoproteins or mAbs



    • Chromatography



    • Tangential flow filtration



  • Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration



  • Due to international nature of the tasks, fluency in written and spoken English



  • Good conceptual, analytical, problem solving, and organizational skills must be detail-oriented, well organized and able to work independently and in teams



  • A "hands-on" energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done



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