Manager, Quality Control Analytical at AstraZeneca

Posted in Other 12 days ago.

Location: Gaithersburg, Maryland

Job Description:

Role Summary

Are you ready to manage a team of QC analysts in the execution and technical transfer of quality control assays? As the Manager of QC Analytical, you will be at the forefront of ensuring our QC analytical laboratory runs compliantly and efficiently. This role requires a strong background in GMP, quality control, and good documentation practices. Join us and be the voice of the patient, monitoring and signing off each batch as if the medicine were for your own family.

Essential Requirements & Experience

  • Lead a Quality Control or GMP testing laboratory and possess up to date knowledge of cGMP and regulatory requirements for cell based products, particularly CAR T-cells.

  • 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.

  • Responsible for working collaboratively within the commercial Quality Control organization to ensure that the QC analytical laboratory is run compliantly and efficiently, and according to regulatory and AstraZeneca requirements.

  • Requires a Bachelor's or Master's Degree in Biological Sciences, chemistry, biochemistry or related field.

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

  • 2+ years of managerial/supervisory experience.

  • In depth knowledge of analytical method development, validation and troubleshooting, with a strong understanding of regulatory requirements.

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

  • Demonstrated ability to make decisions that balance patient safety, compliance and supply.

Preferred Experience

  • LEAN or similar experience

  • Cell therapy analytical testing highly preferred

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. 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 follow evidence to reach outcomes that benefit patients and AstraZeneca. It's an inclusive and friendly community here. We share knowledge and ways of working. Here each voice matters and it instils a real sense of camaraderie.

Are you ready to make a real-life difference to patients? Apply now to join our Operations team as the Manager of Quality Control Analytical!

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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