Senior QC Specialist - Sample and Stability Management*

  • Gaithersburg, Maryland
  • Work experience
  • Quality Management, Quality Assurance
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Senior QC Specialist, Sample and Stability Management *

Become Part of the BioNTech Family.

This position is based in Gaithersburg, MD at our newly formed clinical manufacturing site for BioNTech US. Together with the BioNTech US North American Headquarters in Cambridge, MA, both the Gaithersburg and Cambridge sites are an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies that expects to experience significant growth in the near future. BioNTech US is a subsidiary of BioNTech SE with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US.

Here, you’ll achieve greatness.

You will support the Quality Team with the following: 
  • Primarily responsible for sample management, stability program and material qualification operations of the Quality Control department.
  • Coordinate receipt, aliquoting, testing and shipping of samples for release and stability operations.
  • Maintain stability program and coordinate planning and scheduling activities of the program. 
  • Support tracking and generation of trending charts for monitoring method performance, product quality, invalid rate, and stability.
  • Manage inventory of QC raw materials and consumables to support GMP testing.
  • Coordinate qualification, testing and release of QC raw materials.
  • Author, and review SOPs and Raw material specifications.
  • Lead and author deviations/OOSs, investigations, CAPAs and change control activities as needed.
  • Support qualification/validation of analytical methods, including analytical method technical transfer.
  • Lead and perform integration of required Quality programs into the GMP facility, including GMP materials technical transfer and integration of quality systems (GMP documentation, Deviations, CAPA, Change Control, Training).  
  • Perform routine maintenance of lab equipment and lab spaces.
  • Participate in regulatory inspection readiness activities, as required by Management.
  • Routine maintenance of lab equipment and lab spaces.
  • Lead and participate on teams to support new processes and improve existing processes in the QC labs.
  • Perform other duties as required.

What you have to offer.

  • Master’s degree in scientific discipline with 2+ years of analytical experience or Bachelor’s degree in scientific discipline with 8+ years of analytical experience.
  • Knowledge and experience of stability studies, sample, and QC raw material management.
  • Familiarity with FDA, ICH, GMP guidelines, and quality control processes.
  • Ability to think critically and demonstrate troubleshooting/problem solving skills.
  • Excellent skills in Microsoft Office, data analysis software, and other related applications.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Ability to be flexible with schedule, and work overtime as needed.
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities. 

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Benefits for you.

BioNTech US is committed to the well being of our team members and offers a variety of benefits supporting our diverse employee base. 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, STD and LTD Insurance
  • HRA & FSA Spending Accounts
  • Health & Wellness, including free onsite gym access
  • Adoption & Surrogacy Assistance
  • Vacation and Unlimited Sick Time
  • Holidays and Floating Holidays, including discretionary winter shutdown
  • 401(K) Plan with Significant Company Match
  • Tuition Reimbursement and Professional Development
  • Commuting Assistance and free onsite parking
  • Discounted Home and Auto Insurance
  • Pet Insurance
Plus more benefits that will be shared upon hire!

Have we kindled your pioneering spirit?

Then apply now for our location Gaithersburg (Maryland) and simply send us your application documents using our online form.

For those who require assistance due to disability, or have questions prior to applying, please email careers@join-us.biontech.de.

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!


https://biontech.de/biontech-us

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