Director, MS&T Downstream Laboratory Lead

Gaithersburg US full time Job ID:10717

About the Role:

As a Senior Manager for the MSAT Downstream Laboratory you will provide scientific and strategic leadership to advance BioNTechs antibody and ADC programs. You will play a critical role in designing developing and qualifying downstream processes while fostering innovation and continuous improvement in late-stage development and commercialization.

In this role you will lead a collaborative team environment working closely with internal departments such as Process Development Analytical Development Quality Regulatory Affairs and external partners to ensure seamless technology transfers and GMP readiness. Your expertise will directly support BioNTechs mission to deliver high-quality therapies to patients worldwide.

Your Contribution:

• Provide scientific and strategic leadership for the Gaithersburg MSAT Downstream Laboratory
• Collaborate across teams (Supply Chain Process Development AS&T Analytical Development Quality Regulatory) to establish and run upstream MSAT laboratory operations
• Develop phase-appropriate downstream scale-down models for antibody programs
• Lead knowledge and technology transfers for antibody and ADC programs to enable downstream characterization investigational studies and scale-down model execution
• Coach and develop MSAT team members on downstream antibody manufacturing processes and foster a culture of scientific rigor and continuous improvement
  Design develop characterize qualify downstream processes including chromatography filtration viral inactivation/filtration UFDF concentration/formulation/cryopreservation
• Draft SOPs reports presentations; maintain instrumentation/equipment; troubleshoot issues as needed
• Collaborate with internal teams and external groups to advance late-stage antibody capabilities
• Contribute to PPQ protocol authoring/review ensuring GMP compliance and scientific rigor

A Good Match:

• Masters degree in Biochemical Engineering Chemical Engineering Biomedical Engineering or related discipline with 12 plus years of pharmaceutical/biotechnology process development industry experience.
• In-depth CMC knowledge in early or late-stage antibody technology transfer projects with sound understanding of all stages of antibody drug development (GMP/QbD approach)
• Proven success leading cross-functional CMC teams with strong organizational skills and stakeholder/client management expertise
• Experience as subject matter expert for antibody downstream processes including technology transfer projects/product commercialization
• Demonstrated ability to design complex projects while shaping scientific strategy at both platform/program levels
• Strong collaboration skills across GMP Manufacturing Quality Control/Assurance teams within technology transfer projects

Preferred Qualifications: PhD in a relevant field

US based candidates expected Pay Range: $168100 - $268700/year benefits annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors including responsibilities of the job education experience knowledge skills and abilities.

Inspired Join our team of pioneers and bright open minds. From our founders to our

scientists to our business professionals we think out-the-box believe in ourselves work agile and stand accountable.

Together we usher in a new era of immunotherapies and work on realizing our vision.

Do you have any questions

Please contact Harry Smith(Talent Acquisition) or with reference to the job ID.

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At BioNTech we are more than just a biotechnology company we are a community of innovators scientists and leaders dedicated to

revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide

especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation encouragecreativity and develop

business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and

become part of a mission that has the potential to change lives around the world.

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ethnic or social origin age sexual orientation marital status disability physical appearance health status or any other aspect of personal status.

We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important its a match!