Microbiology Technical Lead, Quality Control

Join our team of pioneers!Based in Cambridge, MA and Gaithersburg, MD. We are committed to improving the health of people worldwide with our fundamental research and our work in the area of development of immunotherapies utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We believe in scientific rigor, innovation and passion as driving forces. BioNTech was founded by scientists and physicians to translate science into survival by combining fundamental research and operational excellence.With decades of deep immunology expertise and experience in developing and optimizing mRNA as part of its broad suite of novel technologies, the company is working with the global community to defeat life-threatening and serious diseases such as cancer, COVID-19, malaria and tuberculosis. The first ever approved mRNA vaccine was created in the labs of BioNTech in Mainz, Germany. A fully integrated immunotherapy powerhouse. We remain focused on bringing our broad pipeline of next-generation immunotherapies and vaccines to people around the world to address cancer, infectious diseases, as well as a growing list of other medical conditions. To accomplish this, we continue to be deeply rooted in science and academic research while also having built a fully integrated, global immunotherapy company with cGMP and GMP manufacturing facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities.Microbiology Technical Lead, Quality ControlThis position is located at the BioNTech Gaithersburg, Maryland, GMP manufacturing site. The Gaithersburg site includes functions supporting cell and gene therapy research, development, and GMP manufacturing operations. These collective functions result in a collaborative environment that is aligned from drug discovery to GMP release of drug product for our patients.The Microbiology Technical Lead is responsible for partnering with managers and site subject matter experts in driving technical functions for the QC Microbiology team, including owning EMPQ planning and execution, rapid and automated system validation, and method validation, to support GMP manufacturing operations.Primary Responsibilities include: * Lead and represent QC Microbiology as a technical SME within cross-functional teams, including execution of EMPQ, Aseptic Process Simulation, disinfectant efficacy, and contamination control programs. * Lead implementation of next generation rapid and automated technologies, supporting sterility, EM, and endotoxin tests. * Lead generation of risk assessments to support QC operations. * Support design of in-process control and release testing strategy for multiple cell therapy products. * Design, author, and execute microbiological technical studies to support current/proposed lab operations and continuous improvement. * Support the technical training function, including design of effective on-the-job performance training, training execution, and continuous improvement. * Review GMP documentation for the QC Microbiology team. * Support generation and revision of new SOPs and testing methods. * Support microbial excursions, lab investigations, deviations, CAPA, and effectiveness verification.What you have to offer.Requirements:*

Bachelor's or Master's Degree with 6 plus years of experience in a QC GMP Microbiology lab. * Experience with safe lab practices and the handling of biological material. * Knowledge of GMPs, GDPs, and regulatory compliant Quality Control processes. * Experience in leading cross-functional projects from initiation to completion. * Experience in leading and/or participating in EMPQ and utility qualifications. * Experience in conducting microbial excursion investigations that resulted in assignable root cause and effective CAPA. * Strong attention to detail and the ability to work cross-functionally. * Excellent communication and organizational skills.Preferred Requirements: * Experience in Rapid Sterility, Endotoxin testing, clean utilities, and QC microbiology lab operations. * Experience in rapid and automated microbial method validation. * Experience in designing and executing risk assessments that determine risk base approaches to QC operations. * Experience in authoring and executing microbial method validation/qualification. * Experience in supporting regulatory inspections, such as conveying clear and concise technical information to auditors.#LI-EJ!Benefits for you:BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to: * Medical, Dental and Vision Insurance * Life, AD&D, Critical Illness Insurance * Pre-tax HSA & FSA, DCRA Spending Accounts * Employee Assistance & Concierge Program (EAP) available 24/7* Parental and Childbirth Leave & Family Planning Assistance * Sitterstream: Virtual Tutoring & Childcare Membership * Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.* 401(K) Plan with Company Match * Tuition Reimbursement & Student Loan Assistance Programs * Wellbeing Incentive Platforms & Incentives * Professional Development Programs * Commuting Allowance and subsidized parking * Discounted Home, Auto & Pet Insurance…and more! More details to be shared.BioNTech is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. BioNTech does not tolerate discrimination against employees or applicants because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, past, current, or prospective service in the uniformed services, genetic information, or any other characteristic protected under applicable federal, state, or local law.If you are unable or limited in your ability to use or access BioNTech's online application tools due to a disability, you can request reasonable accommodations by calling 1-857-228-6231or by e-mailing jobs@biontech.de. Thank you for your interest in BioNTech.