Associate Director, Bioassay

Careerwise Recruitment

Cork

An Associate Director, Bioassay and Analytical Sciences is required by CareerWise Recruitment for our major Cork based biopharma client. Please call Brian Flynn today for further information on 021-4297423 or email: bflynn@careerwise.ie. ROLE: * Lead the Bioassay team and drive all associated activities to support the 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. * Right First Time (RFT) Management of bioanalytical technology transfers. REQUIREMENTS: * MSc. in Cell/Molecular Biology, Biochemistry, Biotechnology, or Analytical Sciences is required. Ph.D. is desirable. * 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. In Search of Excellence. Specialists in the recruitment of Senior Management, Operations, Technical/Engineering, Senior Supply Chain & Quality personnel, Supporting Business Demands & Growth since 1999. This job originally appeared on RecruitIreland.com.

2445 days ago