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Job Details

Process Scientist

Company: Thornshaw Recruitment
Location:
Reference: SM9102
Closing Date: 02 Jan 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

We are recruiting an experienced Biotech Production Specialist with Upstream and/or Downstream Manufacturing experience to join a Biopharma manufacturing facility in the midlands.

Requirements:

Summary of Role

  • Upstream Operations – Including Media Make-up, Inoculum Laboratory, Bioreactor Operations, Primary Recovery Operations. 
  • Downstream Operations – Including, Buffer Make-up, Chromatography, Nanofiltration, Tangential Flow Filtration, Drug Substance Bulk Filling. 


Key Responsibilities: 

  • Operating process & equipment in a clean room environment, in accordance with batch record, user manuals, current standard operating procedures, safety requirements and GMP. Be capable of understanding and responding appropriately to adverse events. 
  • Monitor and collect and trend process data. 
  • Complete tasks required to meet production schedule and batch preparation including equipment set-up and cleaning, receiving and verification of all raw materials, filter integrity testing, running autoclave cycles, sampling, cleanroom housekeeping, i.e. gowning/ consumables stock-up, removal of waste at end of shift 
  • Adhere to validation requirements for new equipment & processes to the appropriate standards. 
  • Assist with the development, review and up-dating of Batch Manufacturing Records, SOPs, and other quality system documentation to support GMP manufacture. 
  • Provide support for other processing activities including media and buffer preparation. Process sampling and sample testing with analytical equipment, pH, conductivity, cell counting, and routine calibration of same. 
  • Identify continuous improvement initiatives and action plans to implement operational excellence and lean practices 
  • Completion of all relevant training on associated Individual Training Plans to complete manufacturing activities in a GMP manner. Provide training on process and equipment as required. 
  • Assist with the schedule and coordination of production activities. 
  • Provide technical input during audits and also to present/ defend production systems, applicable change controls and deviations. 
  • Participate in cross-functional teams on Process Risk Assessments, as applicable, to troubleshoot and resolve technical issues using root cause analysis. 
  • Assist with the generation and execution of process validation protocols and summary reports. 
  • Develop, optimise, scale-up and validate all steps in the upstream process 

Qualification and Experience: 

  • BSc in a relevant discipline (e.g biochemistry, chemistry, process engineering) or equivalent GMP experience. 
  • Ideally 5 years relevant experience in bioprocess development and/or manufacturing, specifically on cell culture / bioreactor systems. 
  • Knowledge of FDA and EU regulations is desirable along with inspection experience. 
  • Strong background in mammalian cell culture and/or purification process unit operations and aware of the potential impact of equipment on biological molecules.
  • Use of Unicorn, AKTA ready, disposable bioreactors, TFF systems an advantage
  • Process characterisation and process validation experience desirable.
  • Good knowledge of GMP essential.
  • Excellent project management capability
  • Excellent verbal and written communication skills. Ability to maintain very clear records of work completed
  • Ability to work effectively as part of a team across all departments


For more information and to apply for this role please call Stephanie on +353 1 2784671 or e-mail smullen@thornshaw.com 

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671

Apply for this job: Process Scientist

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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