Quality Control Scientist II/III*

  • Gaithersburg, Maryland
  • Work experience
  • Quality Management, Quality Assurance
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Quality Control, Scientist II/III*

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.
  We are seeking a highly motivated individual to join us as a QC Scientist II/III in BioNTech’s clinical cell therapy center of excellence located in Gaithersburg, Maryland. In this role, you will work within the Quality Control team in supporting testing associated with manufacturing of exciting new clinical products to fight cancer! This position provides QC analytical testing support for clinical manufactured product and is responsible for product testing, technical transfer support, method qualification, and continuous improvement efforts within the QC team.
 
 

Here, you’ll achieve greatness.

You will support the Quality Team with the following: 
  • Execute analytical methods/SOPs and operate equipment and instruments supporting ELISA, qPCR, ddPCR assays, cell bioassays and Flow Cytometry.
  • Monitor method performance, product quality, reagent usage, invalid rate and/or stability data.
  • Support technical transfer of analytical methods, including comparability testing and co-qualification.
  • Support quality system records, including deviations, lab investigations, OOS, CAPA and change control. 
  • Support QC equipment qualification for new lab equipment and perform routine maintenance of lab equipment and lab spaces.
  • Support review of QC documentation and logbooks.
  • Revise, and review SOPs, technical protocols, and technical reports.
  • Support QC training activities.
  • Support inspection readiness activities.
  • Lead and participate on teams to support new processes and improve existing processes in the QC labs.
  • Lead and support LEAN and 5S efforts as required.
  • Perform other duties as required, including ad-hoc projects to support site and QC team objectives.
  • Execute analytical methods/SOPs and operate equipment and instruments supporting ELISA, qPCR, ddPCR assays, cell bioassays and Flow Cytometry.
  • Monitor method performance, product quality, reagent usage, invalid rate and/or stability data.
  • Support technical transfer of analytical methods, including comparability testing and co-qualification.
  • Support quality system records, including deviations, lab investigations, OOS, CAPA and change control. 
  • Support QC equipment qualification for new lab equipment and perform routine maintenance of lab equipment and lab spaces.
  • Support review of QC documentation and logbooks.
  • Revise, and review SOPs, technical protocols, and technical reports.
  • Support QC training activities.
  • Support inspection readiness activities.
  • Lead and participate on teams to support new processes and improve existing processes in the QC labs.
  • Lead and support LEAN and 5S efforts as required.
  • Perform other duties as required, including ad-hoc projects to support site and QC team objectives.

What you have to offer.



Minimum requirements; Bachelor’s Degree with 5+ years experience in a FDA regulated laboratory, preferably in the biotechnology/biopharmaceutical or related field with Quality Control experience. Experience in laboratory or related field with Quality Control experience

High School Degree and 9+ years’ experience in laboratory with Quality Control experience.

Preffered requirements; Master's degree, lab experience in biotech or pharmaceutical company. 
 

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 Cambridge (Boston) 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!


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