Quality Control, Microbiologist I/II*

  • Gaithersburg, Maryland
  • Work experience
  • Quality Management, Quality Assurance
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Quality Control, Microbiologist I/II (2 Positions)*

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 Microbiologist (Leve I or II) 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 sampling and testing associated with manufacturing of exciting new clinical products to fight cancer! This position provides QC microbiological testing for clinical manufactured product and is responsible for product testing, utility testing, environmental monitoring and continuous improvement efforts within the QC team.
 

Here, you’ll achieve greatness.

 Responsibilities for the Quality Control, Microbiologist I/II include:
 
  • Preferred experience in aseptic technique and clean room operations.
  • Preferred knowledge of GMPs, GDPs, SOPs and Quality Control processes within in QC Microbiology laboratory.
  • Preferred knowledge in pharmacopoeia, and regulatory requirements for QC testing and validation pertaining to the pharmaceutical industry.
  • Ability to aseptically gown to clean room standards (ISO 5- ISO 8) and lift approximately 25 lbs.
  • Preferred knowledge of Quality Systems, including deviations, CAPA, change control, and document management systems.
  • Proficient in MS Word, Excel, Power Point and other applications. 
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
Duties and Job Functions:
 
  • Perform environmental monitoring (EM) of GMP classified cleanrooms. 
  • Perform sampling and testing (e.g. bioburden) of utilities, including purified water and compressed gases.
  • Support data management requirements for the team, including data entry and trending of data utilizing Excel, LIMS, or other trending software.
  • Perform microbiological assays and operations such as Rapid Sterility, Rapid Endotoxin, Gram Stain, Microbial Identification, Growth Promotion, Bioburden, and Plate Reading.
  • Perform data entry and data verification of EM and Utilities.  Author and review final trend reports.  
  • Support QC equipment qualification and perform method qualification to support implementation of sterility and endotoxin testing. 
  • Develop, revise and review SOP’s.
  • Conduct investigations regarding procedural deviations, out of specifications (OOS) results, and address and manage deviations related to microbiological procedures.
  • Identify, author, and review change controls for the QC team.
  • Determine and execute corrective and preventative actions (CAPA) as determined for investigations and OOS. 
  • Review QC raw data, such as testing and logbooks. 
  • Perform 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.
  • 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; High School Degree and 5 plus years experience in Quality Control Lab/GMP related field.  

     

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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