This is a laboratory-based position performing sample management, mechanical force testing, and other component/material characterization testing. Furthermore, this position may assist in data compilation, data presentations, report authoring, and department documentation support.
RESPONSIBILITIES:
The responsibilities of this position include, but are not limited to:
- Work closely with other engineers in the evaluation, development, qualification and implementation of new components and container closure systems
- Support the formulation and process development groups to comply with regulatory requirements and guidance documents related to components and container closure systems
- Author and/or review engineering and development documentation such as component drawings, specifications, assembly drawings, tolerance stack analyses, risk analyses, etc.
- Execute designated test methods and protocols associated with component/device
- Provide general laboratory support, including ordering/replacement of reagents and consumables, general maintenance of equipment, continuous improvement activities, and participating in periodic lab inspections.
- This position will be responsible for preparing data summary presentations, providing data verification support, compiling data, and using lab-based systems for data collection such as electronic laboratory notebooks.
- Flexibility in support of additional biotherapeutics development activities including biophysical & biochemical characterization using techniques such as
- HPLC
- Capillary Gel electrophoresis (CGE),
- Imaged Capillary Electrophoresis (iCE)
- Spectroscopy techniques, light obscuration, microflow imaging