Introduction to role:Are you ready to lead a high-performing QC Microbiology team to protect patients through uncompromising quality and speed to release? Do you want to see your decisions directly influence batch readiness, regulatory confidence, and the delivery of life-changing medicines to people living with rare and devastating conditions?
In this role, you will lead a team of analysts responsible for microbiological control of critical utilities, in-process samples, and finished product testing. You will coordinate daily priorities to keep manufacturing on track, uphold the highest standards of cGMP and GLP, and drive continuous improvement across methods, equipment, and data integrity. Your leadership will ensure robust investigations, timely batch documentation, and a lab environment that is always audit-ready.
You will join a collaborative network of experts who value kindness alongside ambition, where complex challenges are met with scientific rigor and cross-functional problem solving. Here, your technical judgment, coaching, and operational focus will help accelerate safe, compliant supply to patients who rely on us.
Accountabilities:- Team Leadership and Daily Operations: Coordinate work allocation, set priorities, and remove obstacles so analysts complete testing on time for manufacturing and batch release.- Microbiological Control of Utilities and Processes: Oversee routine endotoxin, bioburden, and cleaning validation testing to protect product quality and patient safety.- Method and Equipment Lifecycle: Lead validation, verification, and qualification of microbiological methods and instruments to ensure fitness for purpose and regulatory compliance.- GMP, GLP, and Data Integrity: Embed high cGMP and GLP standards, ensure accurate, contemporaneous records, and perform rigorous technical data reviews.- Investigations and CAPA Effectiveness: Facilitate laboratory and product investigations, apply structured problem solving and root cause analysis, and drive corrective and preventive actions that prevent recurrence.- Quality Risk Management: Lead and participate in Quality Risk Assessments to prioritize controls and mitigate risks across QC operations.- Audit and Inspection Readiness: Represent the QC laboratory during internal and external audits, showcasing robust systems, traceable data, and a culture of continuous improvement.- Troubleshooting and Technical Stewardship: Resolve method and instrument issues rapidly to minimize downtime and maintain throughput.- Operational Excellence: Deliver projects and implement initiatives that improve safety, efficiency, right-first-time performance, and cycle time in the laboratory.- Laboratory Standards and Housekeeping: Maintain a clean, organized, and safe lab that enables reliable results and audit-ready conditions every day.- Knowledge and Capability Building: Keep current with evolving technologies, procedures, and best practices, and coach analysts to raise the technical bar.- Batch Release Support: Ensure timely generation of certificates and utility memos to meet release timelines and business needs.
Essential Skills/Experience:- Lead a team of analysts in QC by coordinating daily operations and ensuring tasks are complete to meet business needs.- Support Utility, routine endotoxin/bioburden and cleaning validation activities on site.- Ensuring high cGMP, GLP standards are maintained while testing.- Support validation/verification and qualification of test methods and processes.- Support equipment qualification as required.- Lead and participate Quality Risk Assessments relating to QC.- Facilitate laboratory investigations and support associated product investigation.- Troubleshoot laboratory methods and instrument problems.- Perform technical review of data generated in laboratory, validation protocols and reports.- Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.- To ensure a high standard of housekeeping is maintained in the Laboratory.- Represent the QC department in internal and external audits where appropriate.- To maintain competence and keep up to date with all new technologies, procedures and methods used in the QC Laboratories.- Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the QC Manager, QA and other relevant departments and to implement effective corrective and preventative actions.- Support on time generation of Certs and Utility memo’s for batch release.
Desirable Skills/Experience:- Experience supervising QC Microbiology in biopharmaceutical or sterile/aseptic manufacturing environments.- Strong working knowledge of pharmacopeial microbiology methods and regulatory expectations for utilities, cleaning validation, and endotoxin/bioburden testing.- Demonstrated success preparing for and participating in regulatory inspections.- Proficiency with LIMS, electronic data integrity principles, and laboratory instrumentation troubleshooting.- Lean, Six Sigma, or operational excellence experience delivering measurable cycle-time and right-first-time improvements.- Effective coaching, performance management, and capability-building for laboratory analysts.- Cross-functional collaboration with Manufacturing, QA, Validation, and Engineering to align testing with production needs.
Why AstraZeneca:Join a mission-driven team where scientific rigor meets human impact. You will work at the intersection of cutting-edge QC science and advanced biologics manufacturing, surrounded by colleagues who bring diverse perspectives to the same table to unleash bold thinking. We pair the pace and autonomy of a biotech setting with the stability and reach of a global organization. Expect an environment that values kindness alongside ambition, where unexpected teams come together to solve complex problems and where your contribution translates quickly into safer, faster supply for patients with the highest unmet needs. Your growth is fueled by real responsibility, modern technology, and leaders committed to helping you do the best work of your career—because every improvement in our lab strengthens the path from breakthrough to patient.
Call to Action:If you are ready to lead with purpose, raise the microbiology standard, and accelerate safe supply to patients who need it most, we want to hear your story today!
Date Posted
17-Jul-2026
Closing Date
26-Jul-2026
Our 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.
