Scientist II/ Senior Scientist, Late-stage formulation development
Location: Gaithersburg, Maryland
Posted: March 08, 2017
Reference ID: R-004492
If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions - join us.
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. As a Scientist II/ Senior Scientist, Late-stage formulation development in Gaithersburg, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
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.
Main Duties and Responsibilities
Scientific and strategic leadership position responsible for late-stage Drug Product formulation development of biologics portfolio. Position entails influencing and executing formulation risk assessments and characterization studies, and developing formulation control strategies. Ensures robustness of intended commercial formulations, suitability for intended use of container closure/ packaging systems, and in-use compatibility with clinical administration components. Authors and reviews marketing applications (BLAs) and supports regulatory responses to approval. Supports lifecycle management of commercial products. Drives scientific objectives and understanding of molecules and mechanisms. Collaborates in a matrix organization with early-stage formulation, process and analytical method development, manufacturing operations (internal facilities and CMOs), marketing, and regulatory affairs to deliver scientific and operational objectives.
Expertise with formulation and biopharmaceutical development, characterization, control strategy, quality risk management, and CMC regulatory guidance and filings for worldwide submissions is required. Experience with successfully taking biologics through to regulatory approval is highly preferred. Experience with novel biologics and/or extractables and leachables is a definite plus. Knowledge of Drug Substance and/or Drug Product manufacturing processes, combination products, and/or comparability protocols/biophysical analytical methods is also a plus. Comfort working collaboratively with multiple groups on technical projects under aggressive timelines is required.
Scientist II: B.S. in chemistry, biochemistry, pharmaceutical sciences, engineering, applied sciences, or related field with a minimum of 13 years of experience, M.S. with a minimum of 10 years of experience, or Ph.D. with a minimum of 3 years of experience.
Senior Scientist: B.S. in chemistry, biochemistry, pharmaceutical sciences, engineering, applied sciences, or related field with a minimum of 15 years of experience, M.S. with a minimum of 13 years of experience, or Ph.D. with a minimum of 7 years of experience.
Can independently and adeptly lead, plan, and execute highly complex projects on tight timelines. Candidate should be a strong scientific thinker in formulation development but also in broader drug development and CMC areas. Displays depth and breadth in scientific and regulatory knowledge. Develops creative solutions to complex problems, but likewise proficient at anticipating and heading off potential issues. Exhibits self-motivation and drive for results. Demonstrates strong scientific leadership and project organizational skills to navigate projects forward. Displays ability to resolve/minimize conflicts through effective interpersonal communications and cross-functional collaborations. Effectively and efficiently explains and presents complex scientific concepts to broad, diverse audiences. Excels at making good decisions, priority setting, and mentoring team members.
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.