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BI
BioNTech SE
last mo.

Senior Director Protein Modality Lead(m/w/x)

Mainz
Full-timeOn-siteSenior

Description

In this role, you will lead the development of protein-based products, ensuring compliance with regulatory standards while fostering a collaborative team environment. Your daily responsibilities will include overseeing product changes, managing deviations, and driving excellence in quality assurance.

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Requirements

  • Degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field
  • Advanced degrees (e.g., MSc, PhD, MBA) highly desirable
  • Extensive experience in R&D Quality or Product Quality
  • Deep understanding of ICH guidelines (Q8, Q9, Q10)
  • Long-term business and pharmaceutical understanding
  • Proven ability to lead and develop teams
  • Exceptional analytical and problem-solving skills
  • Excellent communication and interpersonal skills

Education

Bachelor's degree
OR
Master's degree

Work Experience

approx. 4 - 6 years

Tasks

  • Build and lead a data-driven team
  • Develop and implement a metric-driven leadership approach for protein-based products
  • Ensure alignment with risk management principles and regulatory guidelines
  • Provide leadership for protein-based products from a Quality Assurance perspective
  • Ensure phase-appropriate development while adhering to QMS and GMP standards
  • Oversee critical product changes related to regulatory compliance and quality
  • Guide changes across the product lifecycle for safety, efficacy, and manufacturing
  • Manage critical product deviations impacting compliance and quality
  • Lead thorough investigations and resolutions of product deviations
  • Communicate deviations to mitigate risks and maintain compliance
  • Foster a culture of collaboration and accountability within the team
  • Focus on team development and alignment with organizational priorities

Languages

EnglishBusiness Fluent

Benefits

Flexible Working

  • Flexible hours

More Vacation Days

  • Vacation account

Learning & Development

  • Digital learning
  • Apprenticeships
  • LinkedIn learning

Career Advancement

  • Performance and 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 and impact

Company Bike

  • Company bike

Public Transport Subsidies

  • Job ticket
  • Deutschlandticket

Retirement Plans

  • Employer-funded pension

Childcare

  • Childcare
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