Senior Manager Analytical Development
- 1798 May 04, 2022 Competitive
You will implement commercial and development assays into the lab to support upstream and downstream process development and process characterisation.
You will support commercial and development comparability programs and perform analytical characterisation as well as execution of forced degradation studies. You will assist in development of new assays and trouble-shoot current assays that are being used for release and stability testing of commercial and development products.
Other responsibilities include supporting analytical deviations and CAPAs, authoring and reviewing analytical protocols and reports and authoring the method development, validation and comparability sections of regulatory dossiers.
Qualifications and Skills Required:
- 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.
- Preferred 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 development and execution of process impurity assays including but not limited to qPCR, HCP, antifoam and polysorbate analysis.
- Preferred experience 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).
- Ability to conduct 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.
- Ability to evaluate new equipment/technologies.
- Demonstrated track record of delivering timely and consistent results and familiarity with project management skills.
- 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.