Director, Analytical Development

Bion Environmental Technologies Inc

Gaithersburg, US
Base: $168,100pyear to $268,700pyear; bonus/equity...
On-site
Analytical strategy and execution
Antibody and adc programs
Method development and validation
Your work will drive analytical strategy and execution for antibody and ADC programs, ensuring readiness for regulatory milestones such as BLA submissions

Job Summary

  • Your work will drive analytical strategy and execution for antibody and ADC programs, ensuring readiness for regulatory milestones such as BLA submissions.
  • Partnering with cross-functional teams in Process Development, Global Technical Development, AS&T, Regulatory, and Quality, you will operate primarily in non-GMP laboratories to deliver impactful solutions that shape the future of biologics development.
  • BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce.

Matching Summary

Your work will drive analytical strategy and execution for antibody and ADC programs, ensuring readiness for regulatory milestones such as BLA submissions.

Salary

Base: $168,100/year to $268,700/year; Bonus/Equity: annual bonus & equity (variable); Benefits: comprehensive benefits package

Skills & Requirements

Must-have

  • Analytical strategy and execution
  • Antibody and ADC programs
  • Method development and validation
  • CMC documentation and submissions
  • Cross-functional team collaboration

Nice-to-have

  • Late-stage/BLA readiness experience
  • Commercial launch experience
  • ADC-specific analytics knowledge
  • Global submission experience

Key Requirements

  • PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field with 10+ years of relevant experience
  • MS with 12+ years of industry experience
  • Extensive expertise in global pharma AD/AS&T for monoclonal antibodies or ADCs
  • Proven success leading BLA readiness/PPQ activities
  • Hands-on experience in biologics method development, qualification/validation, transfer processes
  • Strong understanding of biologics CMC guidelines (ICH Q6B)

Work Rights

Not specified

Tailored Resume

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