Quality Control Analyst, Analytical- Cell Therapy at AstraZeneca in Gaithersburg, Maryland

Job Description:

Introduction to role



Are you passionate about quality control and have a strong background in GMP? Do you have a proven track record of high-quality, right first time test execution? If so, we have an exciting opportunity for you as a Quality Control Analyst in our Operations team. This role will see you implementing analytical quality control assays such as flow cytometry, ELISA, PCR, automated cell counting and other cell-based assays, in a GMP lot release setting. Join us and be part of a global team working on diversified tasks and multiple projects!



Accountabilities



As a QC Analytical Analyst, you will be responsible for routine QC lab tasks such as technical transfer, qualification and/or validation of analytical methods, maintenance of equipment and the laboratory as assigned, and writing or revising SOPs, protocols or reports. You will also be responsible for entering data evaluated for compliance to specifications and reporting abnormalities. Your role will require an in-depth knowledge of scientific methods and techniques and the ability to apply critical thought to solving problems.



Essential Skills/Experience:



• Expertise with methods and techniques for analysis of cell therapy products, such as: Flow Cytometry, ELISA, qPCR, dPCR, cell culture, cell count and viability measurement and cytotoxicity assays.


• 2+ years of experience in a pharmaceutical or biotech QC environment, with a focus on cell therapy analytical testing.


• Prior experience in a Quality Control or GMP testing laboratory and knowledge of cGMP and regulatory requirements for cell based products, particularly CAR T-cells.


• Ability to work collaboratively as part of a high performing team.


• Excellent interpersonal, verbal and written communication skills.


• Bachelor's in Biological Sciences, chemistry, biochemistry or related discipline.


• Experience in a cross functional matrix environment.


When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.


At AstraZeneca, we take Quality seriously. Our work is important and valued. We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We are proactive, science-based, and solutions-oriented. Our focus is on scaling and introducing new technologies, using models to predict and proactively manage risk. We are strong communicators and networkers. With constant exposure to different tasks we're at our best when we're working together as a team. We get our pipeline out to patients sustainably, reliably and safely.


Are you ready to make a difference and join us in our journey to deliver life-changing medicines!


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.