Work as part of Analytical Development – Biologics (AD-Bio) team and represent Analytical Development on a cross-functional team. Perform a broad variety of biochemical analytical techniques, including but not necessarily limited to, liquid chromatography, gel or capillary electrophoresis, and/or spectroscopic-based methods; apply knowledge in specialized subdisciplines such as protein mass spectrometry or biophysics; lead cross-program development activities for analytical methods and/or to lead project activities within AD-Bio as functional rep on Global Clinical Trials (GCT); conduct troubleshooting for complex technical issues and to lead characterization studies; perform methods, method development and validation, and transfer of methods to internal and external laboratories; and perform evaluations of new equipment/technologies. Key accountabilities include:
Understanding project timelines and deliverables and planning project work accordingly with departmental, functional and external stakeholders.
Contributing significantly to project work which may include multiple projects within functional area.
Reviewing, interpreting and communicating data cross-functionally within CMC and project teams.
Planning and implementing resolutions to technical problems/issues.
Representing functional area on GCT project teams by communicating activities from designated functional area to project team.
Supporting local and global initiatives.
Serving as a technical resource for junior staff and leveraging expertise in laboratory technology as a functional resource.
Designing and executing experiments, and reporting results.
Assisting with development of project strategy and communicating complex data/decisions within department and cross functionally as necessary.
Building and maintaining relationships with key vendors and assisting with technical aspects of vendor negotiations.
Integrating scientific/technical efforts around cross-functional issues
Must have BS in biological science, pharmacy, or related pharmaceutical science and 8 years of industry experience with analytical development. We will also accept MS and 6 years of experience or PhD and 2 years of experience. Experience must include the following: biochemical analytical techniques, including liquid chromatography, gel and capillary electrophoresis, spectroscopic-based methods, protein mass spectrometry or biophysics; troubleshooting technical issues; performing characterization studies; working with protein structure/function; performing complex methods, method development and validation, and transfer of methods to internal and external laboratories.