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Senior Director Protein Modality Lead(m/w/x)
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
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
English – Business 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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Senior Director Protein Modality Lead(m/w/x)
The AI Job Search Engine
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.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
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
English – Business 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
About the Company
BioNTech SE
Industry
Healthcare
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
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Director GMP Production(m/w/x)
Full-timeOn-siteManagementMainz - BioNTech SE
Director Manufacturing Sciences & Technology(m/w/x)
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Director CMC Materials Lead(m/w/x)
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