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

Job Description:

Senior Analyst, Quality Control Analytical, Cell Therapy




Introduction to role:



Are you ready to foster a mindset of excellence? We are seeking a Senior QC Analytical Analyst to join our Operations team. In this role, you will implement analytical quality control assays such as flow cytometry, ELISA, PCR, automated cell counting and other cell-based assays, in a GMP lot release setting.



Accountabilities:



Your responsibilities will include executing analytical quality control assays, leading technical transfer of assays into the QC Analytical laboratory, troubleshooting methods, participating in lab investigations, writing or revising SOPs, protocols or reports and training or mentoring lower level analysts as needed.



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.


• 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 train others and lead laboratory investigations as required


• Ability to work collaboratively as part of a successful team.


• Excellent interpersonal, verbal and written communication skills in a cross functional matrix environment.


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


• demonstrated ability in a pharmaceutical or biotech QC environment, with a focus on cell therapy analytical testing.



Desired Skills/Experience:



• Master's degree in Biological Sciences, chemistry, biochemistry or related field.


When we put unexpected teams in the same room, we fuel 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 high-reaching world.


At AstraZeneca, we take Quality seriously. Our work is meaningful 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 ambition to go far keeps pushing us forward. But it's our pragmatic focus that keeps us delivering what will have the biggest impact on our patients. We are a team of ambitious people who want to go far and we're all here to achieve. We follow evidence to reach outcomes that benefit patients and AstraZeneca.


Apply now and be part of our journey towards improving outcomes for patients!


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.