Associate Director Bioanalytical Develop

CPL

Dublin South

On behalf of my client, a global biopharmaceutical company, we now have a vacancy for an Associate Director Bioanalytical Development. The Role: As a senior member of the management team, You will provide analytical support for our development, routine manufacture, tech transfer and comparability programs associated with our portfolio of development and commercial biological candidates. The role will involve significant interaction with other Technology Operations team members including the manufacturing and quality teams to ensure in process and release testing of bulk drug substance/product is supported and release and stability data are trended over time. Interaction with other functions including the Regulatory and Project Management (PM) teams. The role requires an ability to work on multiple projects running concurrently; while always looking for opportunities to apply more current technologies and streamline analytics. Qualifications & Experience: • Bachelor’s degree in engineering or an applied science is required. An advanced degree is preferred. • Over five years of relevant analytical development experience in Biologics. • Experience with a broad variety of biochemical analytical techniques, including but not necessarily limited to liquid chromatography, gel or capillary electrophoresis, and/or spectroscopic-based methods. • Experience with cell-based bioassays, BIAcore methods that measure binding kinetics and surrogate bioassays such as ligand-binding ELISA assays in plate based format in Development and GMP format. • Experience with process impurity assays including but not limited to qPCR, HCP, antifoam and polysorbate analysis. • Working knowledge of Mass Spec techniques including MALDI-TOF, Q-TOF, triple quad and quantitative assays by LC-MS/MS. • Familiarity with regulatory guidelines (ICHQ1 to Q3. • Able to conduct independent troubleshooting of multiple methods. • Adept at performing more complex test methods, adaptation of release assays for in-process testing, and transfer of in-process methods to internal and external laboratories with limited supervision. • Able to evaluate new equipment/technologies. • Demonstrated track record of delivering timely and consistent results and familiarity with project management skills. Suitable applications should email their cv to tdunne@thornshaw.com or call me on +353 1 2784671 for a confidential conversation today. This job originally appeared on RecruitIreland.com.

2443 days ago