Manager, Quality Control Microbiology BioNTech is hiring a Manager for QC Microbiology to join our Quality Control team in Gaithersburg, MD. In this role, you will oversee the daily operations of the QC Microbiology team. The QC Microbiology team supports sampling and testing operations for a GMP fill-finish manufacturing facility focused on cell therapy products. The QC Microbiology manager will be managing the daily operations and project related work for team of Microbiologists and ensuring compliant lab operations. In addition, the Manager will be leading QC projects that have high impact to QC operations, such as automation and rapid technology implementation.
Primary Responsibilities Oversee the daily operations of the QC Microbiology team, including sampling cleanroom environments/utilities, QC testing to support GMP manufacturing, and testing cell therapy product. Oversee and lead QC projects that have high impact to QC operations, such as automation and rapid technology implementation. Supervise QC Microbiology lab team members and ensuring team is in compliance with regulations, guidance, and quality standards. Review and approve SOPs, test methods, and procedures, ensuring compliance with regulatory requirements and guidance. Lead and/or manage LEAN and continuous improvement projects for the team. Generate and report performance metrics to drive successes and continuous improvement in lab productivity. Hire, mentor, and develop team members to support business operations and career growth. Ensure compliance of QC equipment calibration and maintenance with local procedures. Supporting, coordinating, and scheduling of training for Quality and manufacturing team members. Supporting internal and external GMP audits. Communicate effectively with management regarding progress, challenges, and needs. Ensure cGMP compliance and participate in regulatory inspections. Requirements: Bachelor's degree in Microbiology or scientific field. 6+ years of GMP laboratory work experience in a regulated environment, including technical leadership. Experience with regulated microbiological assays and equipment. Strong mentoring and multitasking skills. Excellent organizational and critical thinking abilities leading to proven continuous improvement. Effective problem-solving and communication skills. Preferred Requirements: Familiarity with LIMS, ELN, and ERP systems preferred. Experience in managing introduction of new equipment and methods, including rapid and automated methods. Experience with next generation rapid and automation QC testing platforms. 2+ years of technical leadership, including personnel management experience . #LI-EJ1
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.
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