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Join to apply for the Team Lead QC Microbiology AS&T role at BioNTech SEMelbourne, Australia | full time | Job ID: 10521The Team Lead QC Microbiology/AS&T is responsible for establishing and leading QC Microbiology and Analytical, Science & Technology functions for a new clinical manufacturing facility in Australia. This role is pivotal in building the QC microbiology operations from the ground up developing infrastructure, implementing systems, recruiting, qualifying equipment, training staff, and setting up highquality microbiological methods and workflows aligned with TGA, PIC/S, and global GMP standards. As a handson leader, the successful candidate will oversee daytoday microbiology operations, whilst actively contributing to analytical testing, method development/qualification/implementation, and stability programme activities.ResponsibilitiesLead the qualification and operational readiness of the QC Microbiology Laboratory, including procurement, installation, and qualification of analytical equipment.Develop and implement SOPs, workflows, and quality systems aligned with TGA and PIC/S guidelines to ensure GMP compliance, data integrity (ALCOA+), and adherence to compendial requirements.Serve as an SME in method transfer, development, validation activities, and provide technical leadership during OOT/OOS investigations and regulatory inspections.Perform and/or review microbiological testing for cleanrooms, clean utilities, raw materials, product release, and stability studies, while leading environmental monitoring programs, including data review, trend analysis, and investigation of excursions.Oversee method development, transfer, verification, validation activities, and support AS&T activities such as troubleshooting, continuous improvement, and implementation of new microbiological technologies.Recruit, train, and mentor QC microbiology/AS&T staff to build a highperforming team, fostering a culture of safety, quality, and continuous improvement in a dynamic startup environment.Provide coaching and technical development across aseptic techniques, microbiologic method execution, environmental monitoring, and data integrity (ALCOA+).Lead investigations for deviations, OOS, and environmental monitoring trends, and implement CAPAs to maintain adherence to global SOPs and local regulatory requirements (TGA, PIC/S).Prepare for internal audits and regulatory inspections, presenting microbiology data and justifications as the site SME.Partner with QA, MS&T, SCM, and manufacturing to support technology transfers, clinical batch release, facility qualification, cleanroom classification, and utility/system activities.QualificationsBachelor''s degree (or higher) in Microbiology, Biotechnology, or related discipline.Minimum 10 years of QC experience in GMP aseptic manufacturing, including startup or greenfield projects.Experience in building QC microbiology laboratory from ground up, including equipment qualification and SOP development.Ability to work in an evolving environment with limited structure and rapidly changing priorities.Familiarity with clinical trial product requirements and earlyphase manufacturing challenges.Strong knowledge of Australian GMP guidelines, TGA requirements, and PIC/S standards.Proven ability to lead teams and manage complex QC microbiology operations in a fastpaced environment.Excellent communication and stakeholder management skills.Demonstrated expertise in method development, transfer, qualification and validation.Extensive experience in data integrity (ALCOA+), deviation management, OOS/OOT investigations, CAPA and change control systems.Direct experience in supporting regulatory inspections.Excellent verbal and written skills.About BioNTainersWe want to improve healthcare by making our innovations accessible worldwide. Therefore, we developed the first modular mRNAmanufacturing facilities based on a container solution called "BioNTainers". Help us build a regional manufacturing network in Africa & Australia: With the region and for the region. As a part of the local team, driving the establishment of the regional endtoend mRNA manufacturing solutions.BenefitsBioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate''s qualifications and experience.Click here to find out more about what we do, the careers we offer and also the benefits we provide. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company''s internal policies and applicable law.How to applyApply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.Please note: Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ''HireRight''. You will be informed accordingly by your BioNTechRecruiter.We are looking forward receiving your application.#J-18808-Ljbffr