Technical Lead Quality Control Analytical

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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.

Technical Lead Quality Control Analytical 

Primary responsibilities include:

• Lead design, planning, and execution of method validation/qualification/suitability for Flow cytometry, ELISA, PCR, cell-based assay, and other applicable methods to support tech transfer of new processes.  
• Represent QC Analytical as a technical SME in cross-department and cross-site teams.
• Support design and execution of QC Stability studies for multiple products.
• Support design of in-process control and release testing strategy for multiple cell therapy products.
• Troubleshoot testing or technical issues as it relates to methods, equipment, or instruments.
• Monitor method performance, product quality, reagent usage, trending of invalid rate and/or stability data.
• Design and execute technical studies to support current/proposed lab operations and continuous improvement.  
• QC Lead in drafting and supporting risk assessments for multiple cell therapy products.
• Lead the technical training function for the QC Analytical team, including designing on-the job performance training (OJT), scheduling, execution, and continuous improvement.
• Perform a variety of analytical assays, including molecular and cell-based assays.
• Author, revise and review SOPs, equipment validation, method qualification, technical study protocols/reports, and risk assessments.
• Perform data review of QC Analytical testing operations to assure accurate records of work performed and documentation of test results per good documentation practices (GDP).
• Support Equipment qualifications (IQ, OQ, PQ) required in QC Analytical operations.
• Support QC Analytical QMS records, including Deviation, CAPA, and Change Control.
• Ensure compliance of QC Analytical operations to official compendia, health authority regulations and established BioNTech policies.
• Review and approve technical documents for sound analytical concepts and procedures to assure compliance with regulatory expectations.
• Support internal and external audits/regulatory inspections as an SME and interact with auditors and regulatory agencies.
• Other responsibilities, as needed, to support department and site objectives.

What you have to offer. 
Requirements:

• Degree in sciences as follows:
  1. Master’s Degree with 4 plus years of experience in a QC Analytical GMP lab setting.
  2. Bachelor’s Degree with 6 plus years of experience in a QC Analytical GMP lab setting
• Subject Matter Expert in Flow cytometry, ELISA, PCR, molecular and cell-based assays, and other applicable analytical methods.
• Proven record in leading strategy and execution of QC method qualification and method tech transfer.
• Experience working in GMP QC Analytical laboratories that support aseptic sterile GMP manufacturing.
• Experience designing and executing risk assessments to support current and proposed QC testing operations. 
• Ability to participate in regulatory inspections and convey appropriate technical information clearly and concisely.
• Ability to exercise sound judgement and decision making to ensure compliance with regulations under aggressive timelines.
• Experience with safe lab practices and the handling of biological material.

Preferred Requirements:

• Strong attention to detail and the ability to work cross-functionally.
• Excellent communication and organizational 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.