Job Description:
Introduction to Role:
Are you passionate about Science? Do you want to apply your expertise to impact a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you! We put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you'll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.
Accountabilities:
As a Senior Scientist, you will play a crucial role in developing the clinical formulation, Drug Product presentation, and the downstream processes for developing cellular therapy and lentiviral products. You will lead the development of dose preparation and clinical administration aspects of CAR-T products and support the authoring of regulatory and clinical documentations. You will independently plan and execute formulation, cryopreservation process, and fill/finish process development. You will prepare study protocols, reports, technology transfer documentation, and regulatory documents for clinical trials. You will present study results at team, department meetings, to external partners or at conferences. You will perform analytical assays in support of solubility, stability, and elucidation of degradation mechanisms. You should be able to function effectively as a member of one or more project teams. Strong interpersonal, communication and presentation skills and the ability to thrive in a fast-paced dynamic environment are essential.
Essential Skills/Experience:
- Bachelors degree in chemistry, biochemistry, pharmaceuticals, chemical/biochemical engineering or related field
- Bachelors degree with 10 years of experience in biopharmaceutical industry or relevant experience or MS with 5 years or PhD with 0-3 years in biopharmaceutical industry/relevant field experience
- Experience in developing biologics product development including formulation and fill/finish development and characterization and/or cryobiology.
- Experience in handling cell and understanding aseptic techniques is required.
- Experience with developing clinical administration procedures, training on clinical nurses and authoring of dose preparation and handling manuals.
Desirable Skills/Experience:
- Master's degree or Ph.D in chemistry, biochemistry, pharmaceuticals, chemical/biochemical engineering or related field
- Experience in principles and practices of cellular immunology and/or stem cell biology
- Understanding and experience of using the tools of Design of Experiment (DOE) and Quality by Design (QBD) in formulation and process development
- Experience with formulation development, biophysical and biochemical characterization of viruses, protein and viral stability, and analytical methods development
- Experience in flow cytometer, viability, calorimetry, gel electrophoresis, qPCR and cell-based assays along with general knowledge of fill/finish and aseptic operations would be advantageous.
Why AstraZeneca?
At AstraZeneca, we are driven by one mission: finding the best solution to put our patients first. We are united behind this goal and it's what keeps us driving forward as we continuously seek new and better ways to deliver medicines all the way to our patients. Our resilience helps us to thrive as we innovate and evolve. We foster an encouraging, positive environment where ideas are welcomed and rewarded. We are a diverse, multigenerational team of experts connected across the globe. We interpret the science, connecting it with the business need to apply manufacturing excellence. If you enjoy working on a complex variety of activities, then this is the place for you. We apply digital and Lean processes to accelerate us forward. If you want to make a big impact, this is the place for you. Our contribution to life-changing medicines is why people have been here for decades. We do it for the patients.
Ready to make a difference? Apply today and join us in our mission to create life-changing medicines!
Where can I find out more?
Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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