Senior Specialist, Quality Control Analytical*

  • Gaithersburg, Maryland
  • Work experience
  • Quality Management, Quality Assurance
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Senior Specialist, Quality Control Analytical*

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: 
  • Perform 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 and execute analytical methods, including cell bioassays: Flow Cytometry, ELISA, qPCR and ddPCR assays.
  • Track and tests products according to Stability protocols and ensure completeness of the stability data.
  • Perform scheduling, testing, monitoring and verification of method performance, product quality, reagent usage, invalid rate and/or stability data.
  • Train other QC staff on qualified analytical methods.
  • Lead and author deviation/OOS, investigation, CAPA and change control activities and contract labs, as needed
  • Support generation of trending charts for monitoring method performance, product quality, invalid rate and/or stability.
  • Perform Data entry to support analytical method trending.
  • Develop, revise and review SOPs.
  • 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.
  • Experience in any of the following analytical techniques, Flow Cytometry, PCR, ELISA, Cell Viability measurement.
  • 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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