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applicants

Contract Pharmaceutical Process Engineer -11002999

at PDS Tech Inc in United States

RI-West Greenwich



Description
Provide technical support of cell culture processes for commercial manufacturing at our client's or contracted manufacturing sites including process performance monitoring; implementation of process improvement strategies; and development of process models.
Support cell culture process scale-up and technology transfer to commercial facility.
Troubleshoot process and equipment issues arising on the manufacturing floor with cell culture, bioreactors and harvest.
Support operational excellence activities including idea generation, feasibility determination and implementation at manufacturing scale.
Design and execute laboratory and pilot scale experiments in cell culture, harvest and associated areas.
Analyze experimental and plant data, perform statistical analysis and author technical reports.
Lead or participate in cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives.
Perform individually or in teams; execute according to assigned project priority; and meet project timelines.
Review and improve manufacturing procedures, provide input to corrective and preventive actions, assess process and raw material changes, perform root-cause analysis of process failures while ensuring cross-functional collaboration with relevant functional representatives, including Manufacturing,
Facilities & Engineering, EH&S, Quality Assurance, Regulatory, and Validation. Minimal travel may be required.



Qualifications
Basic Qualifications

BS in Biochemical or Chemical Engineering or in a relevant technological field
Three years of experience in cell culture process development or commercial cell culture process support in a cGMP biopharmaceutical environment
Hands-on experience of pilot and large-scale cell culture operation, bioreactor design and control, and harvest technologies using centrifugation and filtration
Experience with the following:

Bioreactor and cell-culture process troubleshooting
Interfacing with manufacturing, quality and supply chain on technical problem resolution
Scale-up and technology transfer of cell culture processes to commercial scale
Preferred Qualifications:

MS or higher degree in Biochemical or Chemical Engineering, or in a relevant technological field
Demonstrated ability in providing cell culture engineering expertise to cross-functional teams to advance complex projects to completion
Ability to compile and statistically analyze data, draw appropriate conclusions and make presentations to cross-functional audience and senior management
Working knowledge of host systems, cell biology, media development and protein structure and function
Basic understanding of quality attributes of protein products and analytical methods for determination of these attributes
Knowledge and understanding of software tools for modeling of fluid flow, mixing, mass and energy balance, and facility utilization
Demonstrated skills in negotiation, conflict resolution and managing customer expectations


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Published at 11-05-2011
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