Stem Cell Technologist - Centre for Cell Manufacturing Ireland (CCMI) Regenerative Medicine Institute (REMEDI) National University of Ireland, Galway Reference number – NUIG 75-13 Applications are invited from suitably qualified candidates for the position of Stem Cell Technologist Centre for Cell Manufacturing Ireland (CCMI) which is based at NUI Galway. This is a 12 month fixed term contract. Significant investment has been made at the Centre for Cell Manufacturing, Ireland (CCMI) at NUI Galway. This investment has seen the development of a 250m2 facility, housing two independent production suites. CCMI is licensed by the Irish Medicines Board to produce medicinal grade human stem cells as Advanced Therapy Medicinal Products (ATMPs) for clinical trials. The CCMI is managed by the Regenerative Medicine Institute (REMEDI) www.remedi.ie which is a Science Foundation Ireland-funded biomedical research centre with a primary goal of studying stem cell biology and translating these findings to new regenerative therapies for human disease. REMEDI is a partnership of scientists, clinicians, and engineers and it is housed at the National Centre for Biomedical Engineering Science (NCBES) at NUI Galway. CCMI will manufacture Human Mesenchymal Stem Cells for Clinical Trials throughout Ireland. The Stem Cell Technologist will be directly involved and play a key role in the manufacturing of the cells and all quality aspects around the manufacturing process for the clinical trials. KEY RESPONSIBILITIES Aseptic processing of clinical grade cell therapy product according to GMP requirements Filling and cryopreservation of clinical grade cell therapy product Maintain batch records and production related records as required Drafting and editing SOP’s and batch records to support cell therapy products Design, draft and perform critical process validations Provide support at the Clinical Trial Site Introduce and implement concepts of lean manufacturing Apply Risk Assessment and Root Cause Analysis Principles Participation in equipment validations as required Training other staff as required Provide support in maintaining cleanroom environment, e.g. cleaning and environmental Monitoring Stock cleanroom suites and support areas with released inventory Maintain and stock clean room environment Perform environmental monitoring duties Inventory control Monitoring equipment specifications and cleaning equipment REQUIREMENTS Bachelor’s degree in Life Sciences or equivalent 2-3 years of experience in a GMP production environment 1-3 years experience in human cell culture Experience in Aseptic technique Experience in SOP writing and report writing Computer software skills including Microsoft Office Highly developed organization and recordkeeping skills Highly developed written and oral communication skills Proven ability to work in a team Ability to work independently and manage multiple projects A strong work ethic Salary: €37,750 Start date: October 2013 Further information about REMEDI is available at http://www.remedi.ie; Informal contacts concerning the post may be made to Aoife Duffy via e-mail to [email protected] Further information on research and working at NUI Galway is available on Research at NUI Galway To apply: Applications to include a covering letter, CV, and the contact details of three referees can be submitted through the NCBES website by using the following link: http://ncbes.eurhost.net/vacancies.aspx Applications must quote ref. no. NUIG – 75-13 in all correspondence. Closing date for receipt of applications is 5.00 p.m. on Friday 6th September 2013 National University of Ireland, Galway is an equal opportunities employer.
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