Company: Thornshaw Recruitment
Closing Date: 19 Nov 16
Salary (£): Negotiable
We are recruiting an experienced Biotech Production Specialist with Upstream and/or Downstream Manufacturing experience to join a Biopharma manufacturing facility in the midlands.
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.
- 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 firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671