Scientific position responsible for late-stage formulation development of biologic products. Design and execute formulation risk assessments and characterization studies, and develop formulation control strategies for Drug Substance and Drug Product. Ensure robustness of intended commercial formulations, suitability for intended use of container closure/packaging systems, and in-use compatibility with clinical administration components. Exercise technical discretion and scientific rigor in experimental protocol design, data analysis, and results interpretation. Author and review marketing applications (BLAs) and support regulatory responses to approval. Develop new strategies and approaches to advance late-stage formulation development. Collaborate in a matrix organization to deliver scientific and operational objectives.
Knowledge of protein biochemistry and degradation mechanisms, biopharmaceutical manufacturing processes, combination drug products, and/or biophysical analytical methods is required. Experience with formulation and biopharmaceutical development, characterization, control strategy, quality risk management, and/or CMC regulatory guidance and BLA filings is preferred. Comfort working collaboratively with multiple groups on technical projects under aggressive timelines is critical, exhibiting self-initiative and drive for results.
B.S. in chemistry, biochemistry, pharmaceutical sciences, engineering, applied sciences, or related field with a minimum of 10 years of experience, M.S. with a minimum of 8 years of experience, or Ph.D. with 0-3 years of experience.
Skills and Abilities:
Can independently lead, plan, and execute projects on tight timelines. Develops creative solutions to complex problems, but likewise proficient at anticipating and heading off potential issues. Demonstrates strong scientific thinking/rigor and project organizational skills to navigate projects forward. Effectively and efficiently explains and presents complex scientific concepts to diverse audiences. Displays ability to resolve conflicts through effective interpersonal communications and cross-functional collaborations. Excels at making good decisions, priority setting, and mentoring team members.
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.