Microbiology Technical Lead, Quality Control

Biontech Ag - Gaithersburg, MD

Part-time - Mid Level

Gaithersburg, MD

Professional, Scientific, and Technical Services

About the position

The Microbiology Technical Lead, Quality Control position at BioNTech is a pivotal role located at the Gaithersburg, Maryland GMP manufacturing site. This site is integral to the company's mission of developing innovative immunotherapies and vaccines, supporting cell and gene therapy research, development, and GMP manufacturing operations. The Microbiology Technical Lead will be responsible for driving technical functions within the QC Microbiology team, ensuring that all microbiological processes align with GMP standards and regulatory requirements. This role requires a strong partnership with managers and subject matter experts to oversee the execution of Environmental Monitoring and Process Qualification (EMPQ) planning, rapid and automated system validation, and method validation to support GMP manufacturing operations. In this role, the Microbiology Technical Lead will represent the QC Microbiology team as a technical subject matter expert within cross-functional teams. Responsibilities include leading the execution of EMPQ, Aseptic Process Simulation, disinfectant efficacy, and contamination control programs. The position also involves implementing next-generation rapid and automated technologies that support sterility, environmental monitoring, and endotoxin testing. The lead will generate risk assessments to support QC operations and design testing strategies for multiple cell therapy products. Additionally, the role encompasses the design, authorship, and execution of microbiological technical studies to enhance lab operations and promote continuous improvement. The Microbiology Technical Lead will also play a crucial role in the technical training function, designing effective on-the-job performance training and ensuring continuous improvement in training execution. Reviewing GMP documentation for the QC Microbiology team, supporting the generation and revision of new SOPs and testing methods, and addressing microbial excursions, lab investigations, deviations, and CAPA are also key responsibilities of this position. This role is essential in maintaining the high standards of quality control that BioNTech is known for, ensuring that all products meet the rigorous safety and efficacy standards required in the biopharmaceutical industry.

Responsibilities

• 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.

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.

Nice-to-haves

• 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.

Benefits

• 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