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 I/II 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
Position is a hands-on, laboratory-based role. The successful candidate will
- Design, optimize, and characterize downstream processes for the manufacture of biopharmaceuticals (monoclonal antibodies and other proteins) in late stage clinical development, validation through commercial launch.
- Be responsible for a significant portion of a purification development project.
- Maintain accurate records of experimental results, review, analysis, and interpretation of experimental data.
- Make periodic presentations in group meetings, project team meetings, and in one-on-one situations.
- Prepare technical reports.
- Support the preparation and review of regulatory documents such as BLAs.
- Support technology transfer to Clinical/Commercial Manufacturing facilities.
- Support troubleshooting and resolution of deviations in GMP manufacturing processes.
- Evaluate new technologies to facilitate process development.
Ph.D. Degree in Biochemistry, Chemical Engineering, or related field. Scientist I, 0-3 years relevant Industry experience, Scientist II level, 3-7 years of relevant industry experience.
- Scientific and/or technical training in process chromatography, ultrafiltration / diafiltration
- Proficiency in protein purification principles and methods including (but not limited to) different modes of chromatography, viral reduction steps and filtration.
- Knowledge of protein chemistry; protein and analytical chemistry, process robustness concepts and process scale-up
- Strong technical writing skills
- Knowledge of statistical design of experiments (DOE); proficiency with statistical software is preferred
- Basic analytical techniques for protein products (HPLC analysis, protein quantification methods, electrophoresis; etc.)
- Highly team-oriented, energetic, critical thinker, organized, capable of significant multitasking with excellent oral and written communication skills
- Experience considered a plus:
- Technical writing in regulatory documents for biopharmaceuticals
- Working knowledge of AKTA systems/software and JMP software
- cGMP manufacturing principles and environments
- Quality by Design, risk assessment / prioritization.
- Expected to be highly team oriented, organized, capable of significant multitasking, able to manage multiple projects with significant independence in a matrix organization, and possess excellent oral and writing skills.
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.