Associate Director, Global QC Microbiology
About The Position
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.
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
- Fluent English (both oral and written) necessary
Nice To Haves
- Previous experience in a leadership function, disciplinary or technical, desirable
- Strong communication skills
Responsibilities
- Lead implementation and optimization of sustainable Contamination Control Strategy and Sterility Assurance across all GMP production platforms, internally and externally.
- Support of 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
