Associate Director Bioassay Development

Location
Cork
Salary
Negotiable
Posted
12 May 2017
Closes
09 June 2017
Position / level
Director, Professional
Contract Type
Permanent
Hours
Full Time

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