Manager, Quality Control Microbiology Testing
Vacancy has expired
Gaithersburg, MD
| Employer: | AstraZeneca |
| Job Type: | Full Time |
Description | |
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Introduction to role: Are you ready to take the lead in a Quality Control Microbiology team? We are seeking a Manager of QC Microbiology to guide a team of QC analysts in the execution and technical transfer of quality control assays. This role requires a strong background in GMP, quality control, and good documentation practices. If you have a proven track record of leadership in a pharmaceutical or biotech environment, this could be the perfect opportunity for you! Accountabilities: As the Manager of QC Microbiology, you will be responsible for ensuring that the QC analytical laboratory operates compliantly and efficiently, adhering to both regulatory and AstraZeneca requirements. You will work collaboratively within the commercial Quality Control organization, playing a critical role in maintaining the high standards of our operations. Essential Skills/Experience: - Prior experience leading a Quality Control or GMP testing laboratory and knowledge of cGMP and regulatory requirements for cell-based products. - Expertise with methods and techniques for analysis of cell therapy products, such as: Sterility via BACT, bioburden, endotoxin, TOC, conductivity and gram staining assays. - Bachelor's in Biological Sciences, chemistry, biochemistry or related discipline. - 7+ years of experience in a pharmaceutical or biotech QC environment, with a focus on microbial testing. - 2+ years of managerial/supervisory experience. - In-depth knowledge of method development, microbial method suitability, 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 under pressure that balance patient safety, compliance and supply. Preferred Skills/Experience: - Experience with Cell Therapy particularly CAR T-cells. 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. We follow evidence to reach outcomes that benefit patients and AstraZeneca. We adapt to get new medicines out quicker. Our focus is on scaling and introducing new technologies, using models to predict and proactively manage risk. We are an inclusive and friendly community where each voice matters. Are you ready to be the voice of the patient? To monitor and sign off each batch as if the medicine were for your own family? To contribute to improving the quality of patients' healthcare and ultimately their quality of life? If so, apply today! 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. | |