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BIOPHARMACEUTICAL STUDY DIRECTOR
Company:THORNSHAW RECRUITMENT |
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Job Reference Number |
14225042 |
Client ID: |
RI/DB6189W |
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Posted On: |
Nov 20 2009 |
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Location: |
CONNAUGHT, MAYO |
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Job Type: |
Permanent |
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Salary: |
NEGOTIABLE |
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Benefits: |
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Applications are invited from candidates who meet the following criteria:
A PhD in a Science discipline (preferably Analytical)
o A minimum of 2-3 years experience working in a GMP regulated environment (EMEA/FDA) within the Pharmaceutical or a CRO industry
o Experience in study design, assay development, validation and project management.
O Experience in analytical techniques e.g. Elisa, Neutralisation assays, other in vitro cell based or in vivo BioAssays.
O Experience in immunology/immunogenicity studies.
Responsibilities will include the following:
o Draw up study plans and implement studies in strict accordance with plan ensuing full regulatory compliance.
O Day to day liaison with clients regarding current and new projects
o Research and develop new methodologies to meet client requirements and/or company strategic objectives.
O Ensure all new methods are validated in accordance with ICH guidelines.
O Ensure all new equipment is qualified and validated in accordance with cGMP and corporate validation requirements and guidelines.
O Generate new and update current standard operating procedures
o Generate protocols, reports and risk assessments.
To find out more about this and other opportunities please send your CV to dbolger@thornshaw.com or call Deirdre on 01-2784671 for further information. For a list of all pharmaceutical vacancies please log on to our website www.thornshaw.com
