Leadership position for late-stage formulation development of biologics responsible for project deliverables and decisions, scientific and organizational objectives, and people development of direct reports. Lead development of intended commercial formulations and container closure/packaging systems to advance late-stage portfolio and support commercial lifecycle management post approval. Lead quality risk assessments and formulation characterization studies, and develop formulation control strategies for Drug Substance and Drug Product. Review marketing applications and support regulatory responses to approval. Interface with stakeholders (regulatory, device development, commercial operations, etc.) to ensure seamless end-to-end product development. Drive scientific initiatives and innovation through personal leadership. Design and implement scientific and business strategies integrated across biopharmaceutical development. Ensure consistent, high-quality project output.
In-depth knowledge of formulation and biopharmaceutical development, protein biochemistry and degradation mechanisms, biopharmaceutical manufacturing processes, combination drug products, and/or analytical and comparability testing strategies is required. Direct experience with formulation characterization, control strategy, quality risk management, and/or CMC regulatory guidance and marketing applications is critical. Knowledge with the commercialization of peptides, antibody-drug conjugates, and/or other biologics is a definite plus. Skills leading, planning, and executing complex projects on tight timelines are important. High degree of self-motivation and drive for results are key.
B.S. in chemistry, biochemistry, pharmaceutical sciences, engineering, applied sciences, or related field with 17 years of experience, M.S. with 15 years, or Ph.D. with 11 years.
Skills and Abilities:
Demonstrates strong scientific knowledge and thinking to navigate project and the business forward. Effectively and efficiently explains and presents complex scientific concepts to diverse audiences. Develops creative solutions to complex problems leveraging scientific and business knowledge, but likewise proficient at anticipating and heading off potential issues. Establishes significant value on internal and external teams, and influences long-term organizational goals and direction. Displays ability to resolve conflicts through effective interpersonal communications and cross-functional collaborations. Excels at making good decisions and priority setting. Demonstrates ability to lead a team effectively and create development opportunities for scientists.
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.