Laboratory-based position responsible for independently designing and executing experiments for late-stage formulation development of biologics, including product characterization, stability, and in-use compatibility studies. Exercise technical discretion and scientific rigor in experimental protocol design, data analysis, and results interpretation. Develop new methods, technologies, and approaches as needed to advance projects to BLA submission and approval. Build end-user requirements and advocacy into commercial product development. Effectively present findings in departmental and inter-departmental meetings and prepare technical reports. Serve as a mentor to other lab personnel.
Position Requirements, Skills, and Abilities:
Experience with protein formulation development and/or analytical biophysical characterization techniques is a must. Hands-on experience with high-performance size exclusion chromatography (HPSEC), particle characterization and sizing (e.g. light obscuration), and aggregate characterization methods are strongly preferred. Understanding of clinical dosage preparation and administration practices is highly desired. Knowledge of risk assessment methodologies and CMC regulatory guidance is a plus. Skills leading, planning, and executing complex projects on tight timelines are important. High degree of self-motivation and drive for results are critical.
For Associate Scientist I, B.S. in chemistry, biochemistry, pharmaceutical sciences, engineering, applied sciences, or related field with a minimum of 5 years of experience or M.S. with a minimum of 2 years of experience is required. For Associate Scientist II, B.S. with a minimum of 8 years of experience or M.S. with a minimum of 5 years of experience is required.
MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and
commercialization of small molecule and biologic prescription medicines. Our talent brings together diverse skillsets with a shared entrepreneurial spirit and a commitment to deep science that can improve the lives of patients. It is our people who enable our success, and as a result we have a robust pipeline that includes more than 120 research projects and product candidates. MedImmune is pioneering innovative research and exploring novel pathways across Oncology; Respiratory, Cardiovascular & Metabolic Diseases; and Infection and Vaccines.