Manager, Quality Control Microbiology Testing

AstraZeneca - Rockville, MD

Full-time - Senior

Rockville, MD

Chemical Manufacturing

About the position

As the Manager of Quality Control Microbiology at AstraZeneca, you will take the lead in guiding a team of QC analysts responsible for executing and transferring quality control assays. This role is pivotal in ensuring that the QC analytical laboratory operates in compliance with both regulatory standards and AstraZeneca's internal requirements. You will collaborate closely with the commercial Quality Control organization, playing a critical role in maintaining the high operational standards that AstraZeneca is known for. Your leadership will be essential in fostering a culture of compliance and efficiency within the laboratory, ensuring that all processes adhere to Good Manufacturing Practices (GMP) and good documentation practices. In this position, you will leverage your extensive experience in a pharmaceutical or biotech environment to oversee the quality control processes for cell-based products. You will be responsible for the technical transfer of assays and will ensure that the laboratory's operations are aligned with regulatory requirements. Your expertise in methods and techniques for analyzing cell therapy products, including sterility testing, bioburden analysis, endotoxin testing, and other microbiological assays, will be crucial in maintaining the integrity of our products. The role requires a strong background in method development, validation, and troubleshooting, as well as a deep understanding of regulatory requirements. You will be expected to make informed decisions under pressure, balancing patient safety, compliance, and supply chain needs. Excellent communication skills are essential, as you will be working in a cross-functional matrix environment, collaborating with various teams to achieve common goals. This position not only demands technical expertise but also a commitment to fostering an inclusive and innovative workplace culture where every team member's voice is valued.

Responsibilities

• Lead a team of QC analysts in the execution and technical transfer of quality control assays.
• Ensure compliance with regulatory and AstraZeneca requirements in the QC analytical laboratory.
• Collaborate with the commercial Quality Control organization to maintain high operational standards.
• Oversee the quality control processes for cell-based products, ensuring adherence to GMP and good documentation practices.
• Utilize expertise in microbiological assays to ensure product integrity and safety.
• Make informed decisions under pressure regarding patient safety, compliance, and supply chain management.
• Foster a culture of compliance and efficiency within the laboratory.

Requirements

• Bachelor's degree in Biological Sciences, Chemistry, Biochemistry, or a related discipline.
• 7+ years of experience in a pharmaceutical or biotech QC environment, focusing on microbial testing.
• 2+ years of managerial or supervisory experience in a Quality Control or GMP testing laboratory.
• In-depth knowledge of method development, microbial method suitability, validation, and troubleshooting.
• Strong understanding of regulatory requirements for cell-based products.
• Excellent interpersonal, verbal, and written communication skills.

Nice-to-haves

• Experience with Cell Therapy, particularly CAR T-cells.

Benefits

• Competitive salary range of $127K - $160K per year.
• Opportunities for professional development and career growth.
• Flexible working arrangements, with an expectation of in-office work at least three days a week.
• A collaborative and inclusive work environment.