Associate Director, Global QC Microbiology

Associate Director, Global QC Microbiology

Gaithersburg, US | full time | Unlimited | Job

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.

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.

• 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) necessaryership experience (disciplinary or technical) is desirable

Expected Pay Range: $146,300/year to $234,100/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities

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
• Sitter stream:
  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…