Associate Director, Global QC Microbiology

About the Role

At BioNTech, we are committed to revolutionizing medicine by translating cutting-edge science into survival. As a Global QC Microbiology Specialist, you will play a pivotal role in ensuring patient safety and regulatory compliance across our GMP production platforms. Your expertise will contribute to optimizing contamination control strategies and sterility assurance, directly impacting the quality of our products and advancing our mission to address diseases with high medical needs. In this role, you’ll collaborate closely with internal teams and external partners to uphold the highest standards in microbiology and quality control. You’ll be part of a dynamic environment that fosters innovation and supports your professional growth while contributing to groundbreaking advancements in medicine. Located in the BioHealth Capital Region near Washington DC and ranked among the top biopharma hubs in the country, Gaithersburg, Maryland offers a unique and diverse cluster across industry, government, and academia for top talent and scientific innovation. As a pivotal player within the life sciences community, Gaithersburg is distinguished by its robust infrastructure and strategic location near the nation’s capital. The city’s strategic significance is amplified by its state-of-the-art manufacturing facilities that cater to the rigorous demands of the life sciences industry; Gaithersburg’s manufacturing sector is defined by advanced technologies and complies with the most stringent regulatory standards, ensuring the production of high-quality pharmaceuticals, biologics, and medical devices. In the coming years, Gaithersburg will continue to be a vital contributor to the future of medical science and technology.

Responsibilities

• Lead implementation and optimization of sustainable Contamination Control Strategy and Sterility Assurance across all GMP production platforms, internally and externally.
• Support auditing activities and risk analysis to ensure patient safety and regulatory compliance.
• Oversight for QC activities at CDMOs and external laboratories, including the approval of standard operating procedures within the field of responsibility.
• Oversee QC activities of BioNTech internal microbiology labs, CDMOs / MNPs or external laboratories in line with relevant Quality Agreements such as:
• Monitoring and evaluation of relevant release testing results of batches produced by CDMOs
• Ensuring that the QC certification of batches and documents complies with regulatory requirements
• Review and approval of QC-relevant documents (e.g., specifications, analytical validation protocols and reports, investigation reports, stability documentation)
• Authoring of global SOP/standards.
• Implementing strategy regarding microbiology related systems, e.g., LIMS, eQMS, equipment, etc.

Requirements

• University degree in a scientific/life-science-related field; Advanced degree desirable
• Minimum of 7-10 years of experience in QC (primarily in Microbiology) within the pharmaceutical industry
• Profound experience in GMP and CMC development, including commercialization
• Experience in managing QC labs/CDMO partners
• Regulatory body interface
• Solid analytical background, experience in clean room qualification
• Previous experience in a leadership function, disciplinary or technical, desirable
• Strong communication skills
• Fluent English (both oral and written) necessary
• Leadership experience (disciplinary or technical) is desirable

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