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Associate Director Late Stage Formulation Development

Gaithersburg, MD

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MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
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.
Position Requirements:
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.
Education Requirements:
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
Excels at making good decisions and priority setting. Demonstrates ability to lead a team effectively and create development opportunities for scientists.
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law
AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
Date Posted
09-Aug-2018 Closing Date

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