Manufacturing Lead, GMP eBR

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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.

Manufacturing Lead, GMP eBR 

Primary responsibilities Include:

• Lead’s primary responsibility is to ensure that the deployment of the Werum/Koerber PAS-X electronic Master Batch Records are successfully and compliantly designed, developed, deployed, and supported to maximize business benefits and are in line with site business process and technical standards.
• Lead will also be accountable for driving MES training, collaboration, benefit realization, and standardization across the site.
• Lead is responsible for following standard processes and procedures in performing their duties. These include cGMP regulations, SOPs and global business processes.
• Partner with local Tech Ops, Quality, and Operations resources as well as outsourced contracted services to design, develop, revise, train, and sustain electronic Master Batch Records, bringing together knowledge of manufacturing processes, and standard Koerber generic master batch record (GMBR) configuration.
• Collaboration in the validation of recurring MES maintenance releases & updates by creation and execution of test cases and changes for the validation of MES systems in a GMP production.
• Executes the appropriate change control and electronic Master Batch Record life-cycle actions and processes to assure the MES system is in a state of control and compliance,
• Responsible for the creation and execution of the site MES SOPs and Koerber training strategy and sustainment for end users.
• Collaborates and assists with troubleshooting to efficiently resolve manufacturing problems, providing MES support to ongoing Electronic Batch Record (EBR) operations.
• Identifies and implements continuous process improvement opportunities.
• Knowledge of Quality Systems and Regulatory Standards to provide assurance and foster quality decisions with project teams and their site Quality unit.
• Assists in external agency inspections as needed.

What you have to offer
Requirements:

• Bachelor’s Degree with a minimum three (3) years of MES support experience within a production regulated industry.
• Strong understanding of manufacturing principles/processes and ability to translate manufacturing requirements into Automation/Digital Solution.
• Proven track record of analytical skills, problem solving and attention to detail.
• High personal integrity, credibility, and energy.
• Excellent communication and influencing skills.
• Strong written and verbal communication skills.
• Experience with Project Management and/or Change Control.
• Must possess a positive attitude and promote BioNTech’s Core Values.
• Ability to work on-site.

Preferred Requirements:

• Knowledge about MES (Preferably Koeber Pharma Pas-X)
• Knowledge of SAP
• Knowledge of LIMS (Preferably Labware)
• Knowledge of MSI Integration

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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.