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BioNTech SE
2mo ago

Director Manufacturing Sciences & Technology(m/w/x)

Mainz
Full-timeOn-siteSenior

Description

In this strategic leadership role, you will be the technical voice for RNA and antibody products, ensuring compliance and driving excellence throughout the product lifecycle, from development to post-launch support.

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Requirements

  • •Advanced degree in Biotechnology, Biochemistry, Chemical Engineering, or related field
  • •Extensive experience in late-stage product development, commercial manufacturing, and technical lifecycle management
  • •Proven track record in CMC leadership, including technical transfer, regulatory submissions, and post-approval change management
  • •Deep understanding of RNA and antibody-based products, control strategies, and regulatory compliance
  • •Demonstrated ability to lead cross-functional teams and manage complex technical projects
  • •Excellent verbal and written communication skills
  • •Strong interpersonal skills and experience managing strategic partnerships with global collaborators
  • •Analytical mindset with a proactive approach to identifying and mitigating risks
  • •Experience with Biologics License Applications (BLA) and Responses to Questions (RTQs)
  • •Familiarity with Good Manufacturing Practices (GMP) and Annual Product Reviews (APRs)
  • •Expertise in managing Post-Approval Change Management Plans (PACMP)

Education

Master's degree

Work Experience

approx. 4 - 6 years

Tasks

  • •Ensure compliance with regulatory dossiers
  • •Advocate for technical excellence
  • •Develop strategies for technical lifecycle management
  • •Lead the Commercial CMC Team
  • •Drive late-stage technical transfer
  • •Ensure Biologics License Application readiness
  • •Oversee Responses to Questions and launch support
  • •Manage GMP manufacturing investigations
  • •Monitor process performance and Annual Product Reviews
  • •Manage Post-Approval Change Management Plans
  • •Identify and mitigate product risks
  • •Drive technical improvements across the product lifecycle
  • •Provide guidance and training to MS&T staff
  • •Build strategic alliances with key partners
  • •Act as the primary interface for strategic partnerships
  • •Support product manufacturing with robust control strategies
  • •Lead investigations into GMP manufacturing issues
  • •Monitor and analyze product performance

Languages

English – Business Fluent

Benefits

Flexible Working

  • •Flexible hours

More Vacation Days

  • •Vacation account

Learning & Development

  • •Digital learning
  • •Apprenticeships
  • •LinkedIn learning

Career Advancement

  • •Performance & talent development
  • •Leadership development

Other Benefits

  • •Your voice at the table
  • •Support for your full potential

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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