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 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
This position can be filled at Scientist II or Senior Scientist level depending upon experience.
You will represent Analytical Function in late-stage CMC Development, manage analytical technology transfer into the Large Scale Manufacturing and Commercial space involving internal, external, and joint-venture partners, and key contact for authoring and review of regulatory submissions such as BLA, MAA and JNDA. In addition, you will author documentation including, but not limited to, justification of specifications, comparability, QBD risk assessments, and responses to regulatory agency questions, have significant scientific input on CQAs, robustness and validation studies and risk assessments, work with cross-functional (matrix) management, and be responsible for multiple projects.
BS with 8-12 years of experience in the biopharmaceutical industry, or MS with 6-10 years of experience in the biopharmaceutical industry, or PhD with 3-8 years of experience in the biopharmaceutical industry
* Technical expertise in chromatography (HPLC, UPLC) and/or electrophoresis (CE-SDS, cIEF)
* Experience with cross-functional (matrix) management
* Analytical method tech transfer, qualification and validation experience
* Strong background involving analytical experience across CMC with significant late-stage biologics
* Experience with regulatory submissions (IND, BLA, MAA, JNDA)
Desirable Requirements* Outstanding organizational and communication skills (especially written, verbal and presentation)
* Previous experience managing tech transfers and CROs/ CMOs
* Ability to handle multiple projects at one time
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.
A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca