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BioNTech SE
3mo ago

Analytical Method Expert (Associate Director AS&T Lifecycle Management)(m/w/x)

Mainz
Full-timeOn-siteSenior

Description

In this role, you will play a crucial part in product development and regulatory submissions for RNA and protein-based therapeutics. You will ensure that analytical methods meet GMP standards while collaborating with cross-functional teams and external partners.

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Requirements

  • •Advanced university degree in a scientific discipline
  • •Industry experience in CMC development/commercial
  • •Background in organic chemistry and/or Biologics product development
  • •In-depth knowledge of analytical techniques with hands-on experience in assay development and validation
  • •Experience with HPLC, GC, mass spectrometry, NMR, and IR techniques
  • •Experience with chromatographic, spectroscopic, electrophoretic, immunoassay and molecular biology techniques
  • •Experience with cell-based and immunoassays, molecular biology and physicochemical techniques
  • •Expertise in analytical control strategies and method validation concepts
  • •Experience in intercultural, cross-functional teams
  • •Structured way of working and ability to break down complex challenges
  • •Highly motivated and willingness to work in a fast-paced environment

Education

Master's degree

Work Experience

5 years

Tasks

  • •Provide technical analytical expertise for late-stage and commercial projects
  • •Ensure compliance with GMP standards and industry guidelines
  • •Develop method validation and transfer strategies
  • •Manage method lifecycle activities, including reagent exchange and laboratory investigations
  • •Engage in strategic and technical discussions with CMC team members and external partners
  • •Evaluate and review technical and regulatory submission documents
  • •Act as the analytical subject matter expert for regulatory filings
  • •Respond to inquiries from health authorities regarding regulatory submissions

Tools & Technologies

HPLCGCmass spectrometryNMRIR techniques

Languages

English – Business Fluent

Benefits

Flexible Working

  • •Flexible hours

More Vacation Days

  • •Vacation account

Learning & Development

  • •Digital learning
  • •Apprenticeships
  • •LinkedIn learning

Mentorship & Coaching

  • •Performance & talent development
  • •Leadership development
  • •Support for your full potential

Startup Environment

  • •Your voice at the table

Informal Culture

  • •Culture on an equal footing

Purpose-Driven Work

  • •Opportunities to shape & impact

Company Bike

  • •Company bike

Public Transport Subsidies

  • •Job ticket
  • •Deutschlandticket

Retirement Plans

  • •Employer-funded pension

Childcare

  • •Childcare
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