Analyst, Quality Control Microbiology, Cell Therapy

AstraZeneca - Gaithersburg, MD

Full-time - Entry Level

Gaithersburg, MD

Chemical Manufacturing

About the position

As a QC Microbiology Analyst in our Operations team, you will play a significant role in performing microbial quality control assays such as bioburden, endotoxin, sterility, and other microbial assays. This position requires a strong background in Good Manufacturing Practices (GMP), quality control, and good documentation practices, along with a consistent record of high-quality, right-first-time test execution. You will be the voice of the patient, taking pride in monitoring and signing off each batch as if the medicine were for your own family. In this role, you will be responsible for implementing methods and techniques for the analysis of cell therapy products, including bioburden, endotoxin, gram staining, and sterility testing. 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 Standard Operating Procedures (SOPs), protocols, or reports. It is essential that you read, understand, and follow SOPs and comply with current Good Manufacturing Practices (cGMPs). Your role will require critical thinking to tackle problems and an in-depth knowledge of scientific methods and techniques.

Responsibilities

• Perform microbial quality control assays such as bioburden, endotoxin, and sterility testing.
• Implement methods and techniques for analysis of cell therapy products.
• Handle routine QC lab tasks including technical transfer testing and validation of microbial methods.
• Maintain equipment and the laboratory as assigned.
• Write or revise SOPs, protocols, or reports.
• Read, understand, and follow SOPs and comply with cGMPs.
• Utilize critical thinking to solve problems related to microbial testing.

Requirements

• Bachelor's degree in Biological Sciences, biology, microbiology, or a related field.
• 2+ years of experience in a pharmaceutical or biotech QC environment, focusing on microbial testing.
• Prior experience in a Quality Control or GMP testing laboratory.
• Knowledge of cGMP and regulatory requirements for cell-based products.
• Ability to work collaboratively as part of a team.
• Excellent interpersonal, verbal, and written communication skills.

Nice-to-haves

• Experience with cell-based products, particularly CAR T-cells.

Benefits

• Competitive salary
• Health insurance
• Retirement savings plan
• Paid time off
• Professional development opportunities
• Flexible working arrangements