Manager, Quality Control Microbiology

8 months ago

Employment Information

Industry Quality Assurance Engineer

Experience Fresh

Location Gaithersburg, MD 20878, Gaithersburg, United States of America

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Based in Cambridge, MA and Gaithersburg, MD. We are committed to improving the health of people worldwide with our fundamental research and our work in the area of development of immunotherapies utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We believe in scientific rigor, innovation and passion as driving forces. BioNTech was founded by scientists and physicians to translate science into survival by combining fundamental research and operational excellence.

With decades of deep immunology expertise and experience in developing and optimizing mRNA as part of its broad suite of novel technologies, the company is working with the global community to defeat life-threatening and serious diseases such as cancer, COVID-19, malaria and tuberculosis. The first ever approved mRNA vaccine was created in the labs of BioNTech in Mainz, Germany. A fully integrated immunotherapy powerhouse. We remain focused on bringing our broad pipeline of next-generation immunotherapies and vaccines to people around the world to address cancer, infectious diseases, as well as a growing list of other medical conditions. To accomplish this, we continue to be deeply rooted in science and academic research while also having built a fully integrated, global immunotherapy company with cGMP and GMP manufacturing facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities.

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.

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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.

If you are unable or limited in your ability to use or access BioNTech’s online application tools due to a disability, you can request reasonable accommodations by calling 1-857-228-6231or by e-mailing jobs@biontech.de. Thank you for your interest in BioNTech.