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Analyst, Quality Control Microbiology, Cell Therapy

1 month ago

Rockville, United States AstraZeneca Full time
Job Description

Analyst, Quality Control Microbiology, Cell Therapy

Join us as a QC Microbiology Analyst in our Operations team, where you will play a significant role in performing microbial quality control assays such as bioburden, endotoxin, sterility, and other microbial assays. This role requires a strong background in GMP, quality control, good documentation practices and a consistent record of high quality, right first-time test execution. Be the voice of the patient and take pride in monitoring and signing off each batch as if the medicine were for your own family.

Accountabilities:

As a QC Microbiology Analyst, you will be responsible for implementing methods and techniques for analysis of cell therapy products, such as: bioburden, endotoxin, gram staining, and sterility. You will handle routine QC lab tasks such as technical transfer testing, qualification and/or validation of microbial methods, maintenance of equipment and the laboratory as assigned, and writing or revising SOPs, protocols or reports. You will be expected to read, understand, and follow SOP’s and comply with cGMP’s. Your role will require critical thinking to tackle problems and an in-depth knowledge of scientific methods and techniques.

Essential Skills/Experience:

• Bachelor’s in Biological Sciences, biology, microbiology, or related field.

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

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

• Ability to work collaboratively as part of an impactful team.

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

Preferred Skills/Experience:

• Experience with cell-based products, 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 high-reaching world.

Why AstraZeneca?

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 ambition to go far keeps pushing us forward. 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.

Ready to make a difference?

Apply now to join our team

Date Posted

21-Jul-2024

Closing Date

01-Sep-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.