Scientist I/II Non-Protein Biologic Therapeutics AstraZenecaLocation: Gaithersburg, Maryland, United States
Job reference: R-040632
Posted date: Dec. 10, 2018
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. Here at MedImmune, 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.
Major Duties and Responsibilities:
Lead downstream process and technology development for next generation non-protein biologic therapeutics potentially including nucleic acids, RNAi, mRNA, DNA, gene therapy, therapeutic vaccines, oncolytic viruses, cellular therapies including Chimeric antigen receptor T-cell (CAR-T) therapies, and stem cell therapies. You will be responsible for development, implementation, and execution of long term portfolio wide strategy for downstream processing of non-protein biologic therapeutics. The candidate will solve challenging downstream processing problems potentially including cell therapy activation and separation, mRNA purification, viral vector and virus purification, and bioprocessing of regenerative and stem cell therapies. The role will focus on development of scalable technologies suitable for cGMP processing. The candidate will work closely with other functions in the Biopharmaceutical Development organization to minimize development timelines and achieve optimal process design and integration. In particular, the ideal individual will coordinate seamlessly with the cell culture, analytical, and formulation groups to solve challenging problems in non-protein biologic therapeutics. The candidate should maintain accurate records of data and actively participate in laboratory organization. The individual should professionally deliver project plans and updates, possess excellent writing and communication skills, and show attention to detail to support the preparation and review of development reports, presentations, and regulatory filings. Job complexity: The job is very complex, requiring an understanding of the biological and chemical properties of non-protein biologic therapeutics, process design, data analyses, and regulatory requirements.
M.S. or Ph.D. in biochemistry, biology, chemical/biochemical engineering, or related field.
Scientist I: MS 8+ years of experience,PhD some relevant experience preferred
Scientist II: MS 10+ years of experience,PhD 3+ years of experience
Detailed understanding and strong background in downstream processing of non-protein biologic therapeutics required. Experience developing purification processes for non-protein biologic therapeutics potentially including nucleic acids, RNAi, mRNA, DNA, gene therapy, therapeutic vaccines, oncolytic viruses, cellular therapies including Chimeric antigen receptor T-cell (CAR-T) therapies, and stem cell therapies highly desirable. Fundamental understanding and practical experience with development of scalable downstream processes for cGMP manufacture of non-protein biologic therapeutics highly desirable. Strong background and hands-on experience with process chromatography development for cGMP manufacture of nucleic acids potentially including RNAi, mRNA, DNA, gene therapy, and plasmid DNA highly desirable. Strong background and hands-on experience with downstream process development for cGMP manufacture of cellular therapies including CAR-T therapies and stem cell therapies highly desirable. Good knowledge and practical experience with scalable separation techniques for cellular therapies including continuous centrifugation highly desirable. Experience with viral vector and virus purification including oncolytic viruses highly desirable. Experience with scalable virus purification techniques potentially including continuous density gradient centrifugation desirable. Experience with tech transfer to pilot and clinical manufacturing desirable. Experience with regulatory requirements and filings including IND/IMPD for non-protein biologic therapeutics desirable. Good oral and written communication skills required. Must be team player and customer focused.
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.