Manufacturing Compliance Lead

Join our team of pioneers!

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 Compliance Lead 

Primary responsibilities Include:

• Generate, own, and provide subject matter expertise to Quality System records as minor/major deviations, CAPA and change control records.
• Lead investigations for Quality deviations and incidents as required. Conducts Quality investigations with focus on performance improvement and risk reduction.
• Perform walkthroughs of areas where deviation occurred and ensure thorough understanding of associated manufacturing processes.
• Collect and evaluate documentation required to support investigation (i.e. logbooks, batch records, test results, etc.)
• Develop a comprehensive understanding of the manufacturing processes and the associated risk management control strategy developed to identify process risks around the associate processing steps.
• Organize and lead cross functional team meetings including initial and follow up meetings to ensure robust investigation conclusions, effective communication, and sharing of learnings.
• Drive the identification and implementation of effective CAPAs to support reduction in reoccurrence and prevention.
• Coordinate review of investigation with Team Leads, Area Managers, Site Quality Authority, Subject Matter Experts, etc., address review comments, obtain alignment and ensure approval and closure of the investigation.
• Manage workload and ensure adherence to a 30-day investigation closure process, including escalation of roadblocks which could result in delays.
• Ensures required management and Quality approvals on final investigations while satisfying established due dates.
• Provide overview of investigations during regulatory inspections, internal audits and customer audits and respond to verbal and written inquiries.
• Continuously monitors and trends deviation and CAPA performance and provides regular updates and recommendations to senior leadership.
• Will be required to perform task of walking the process and understanding the areas in which the incidents occurred which may require periods of standing and gowning into cleanroom environments, such as, Grade D, Grade C, and Grade B.
• Will be required to write investigational reports within the enterprise system which will require periods of sitting/typing.

What you have to offer
Requirements:

• Bachelor’s Degree in Life Sciences or Engineering with 3 years of experience in a GMP manufacturing environment, with a focus on CAPA’s, Change Controls, and Deviation Investigations.
• Strong understanding of regulatory requirements related to CAPA, change controls, and deviations.
• Experience leading cross-functional teams and driving process improvements.
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills.
• Must possess a positive attitude and promote BioNTech’s Core Values.
• Ability to work on-site, daily.

Preferred Requirements:

• Previous cell therapy experience; pre-clinical, clinical, and/or commercial.
• Pro-active, result driven, and ability to prioritize work to meet deadlines.
• Ability to perform complex data analysis and effectively drive problem solving.
• Ability to translate highly technical information into easily understandable information for manufacturing operators.
• A fact-based problem solver with strong troubleshooting and problem-solving skills.

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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.