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Associate Director

Reference:ASVQ-348262
Location: Cork
Qualification:Doctorate
Experience:10+ Years
Job Type:Permanent
Salary:Not Disclosed
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Associate Director Bioassay Development
Our client, a global biopharmaceutical company are currently recruiting for an Associate Director for their Bioassay and Analytical Sciences team. The Associate Director will manage a team of scientists so previous people management experience is essential. You will be responsible for testing assays such as, cell-based bioassays, immunoassay and nucleic acid assays to support the development of Biologics.

Responsibilities
• Lead the Bioassay team and drive all associated activities to support of global R&D portfolio
• Develop and implement the bioassay strategy for managing development programs, data analysis & trending across the global organization
• Prioritize, innovate and manage knowledge to deliver outstanding scientific & operational performance
• Provide regulatory support for IND/NDA/BLA submissions
• Manage the departmental operational and portfolio budgets
• Responsible for developing the required talent to drive technical excellence and leadership in Bioassay and Stability Sciences
• Right First Time (RFT) Management of bioanalytical technology transfers
• Support investigations & troubleshooting and drive continuous improvement initiatives
• Ensure Phase appropriate cGMP compliance in all aspects of laboratory and Analytical Science operations

Requirements
• Ph.D/MSc. in Cell/Molecular Biology, Biochemistry, Biotechnology, or Analytical Sciences is required.
• A minimum of 10 years’ experience within the biopharmaceutical industry focusing on Large Molecules Analytical Development
• A minimum of 5 years of prior management experience with accountability for individual performance management
• Strong scientific background in biological methods, excellent knowledge of relevant ICH guidelines and good understanding of FDA/EMEA regulatory requirements applicable to biologics
• Proficient in cell biology/cell culture, strong problem solving skills, expertise in technology transfer, qualification/validation requirements for cell-based bioassays and binding assays, Immuno-chemistry and DNA experience is required
• Proficient in experimental design, bioassay development, bioassay data reduction, reporting and statistical analysis
• Strong people leadership profile in complex, technical teams in a global dynamic environment
• Excellent communication skills (verbal, written & presentation) and project management skills



If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252




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