MedImmune currently has an opening for an R&D Associate I/II in Gaithersburg, MD. This position will focus on device development.
The role holder will be responsible for the assessment, selection and testing of primary packaging components, drug delivery devices and secondary packaging within the Drug Delivery & Device Development group. The role holder will also be responsible for the generation of Design History File documentation and for supporting the design and development activities for multiple device projects.
Major Duties and Responsibilities:
- Conduct feasibility/engineering assessments to enable selection of platform drug delivery device technologies.
- Generate test methods and conduct laboratory testing of primary packaging components, delivery devices and secondary packaging.
- Author test protocols and technical reports to support device development for multiple projects.
- Apply regulatory guidances and industry standards to device design and development.
- Generate and maintain Design History File documentation.
- Collaborate with internal customers, component/device suppliers and external development partners.
- Participate in problem solving and trouble-shooting activities related to primary packs and devices.
- Maintain awareness of recent technical developments in the field of injectable drug delivery.
- Present technical data at various project team and department meetings as needed.
Requires in-depth knowledge of mechanical/biomedical engineering principles, computer-aided design and manufacturing processes. A good understanding of the pharmaceutical/biopharmaceutical industry and experience within biotech is preferred.
B.S. or M.S. degree in Mechanical or Biomedical Engineering or related field. Experience of 0-5 years (B.S.) or 0-2 years (M.S.) in the medical device, pharmaceutical or biotech industry.
MedImmune works to boost the immune systems of babies and grown-ups. Its flagship biotech product, Synagis, prevents respiratory syncytial...