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Sr Director Drug Substance Facility Lead(m/w/x)
As a Senior Director Drug Substance Facility Lead, you will oversee the production of high-quality biologics, ensuring compliance and optimizing processes while fostering a culture of safety and accountability. This role involves strategic planning, resource management, and driving continuous improvement initiatives to enhance operational efficiency.
Requirements
- Bachelor’s degree in biology, chemical engineering, or related discipline or equivalent
- At least 12 years of experience in GMP manufacturing in pharmaceutical or biotech industry
- Master’s degree with at least 10 years of experience in relevant position
- Experience in commercial drug substance manufacturing using mammalian cell culture
- Experience in upstream and downstream processing
- Experience in tech transfer and leading cross-functional teams
- Working knowledge of cGMP regulations across multiple markets
- Demonstrated supervisory and leadership skills
- Experience as manager of managers
- Excellent oral and written communication skills in English
- Qualification and training in economics and LEAN management
- Accountability and budget management skills
- Business performance management and planning skills
- Client relationship building and customer-focused approach
- Data-driven decision making and continuous improvement
- Leadership and people leadership skills
- Manufacturing quality control and scale-up experience
- New product introduction process experience
- Process engineering skills
Tasks
- Oversee drug substance production operations
- Provide functional leadership in production support areas
- Ensure compliance with cGMP, FDA, and quality standards
- Implement and monitor safety protocols
- Create production plans with cross-functional teams
- Optimize resource allocation for cost-effective practices
- Identify and implement process improvements
- Establish governance structures for site performance
- Communicate BPR&D and site strategies to employees
- Drive accountability across cross-functional teams
- Set and monitor key performance targets
- Develop organizational culture focused on empowerment and inclusion
- Lead recruitment, training, and performance management
- Establish succession plans for operations
- Build strong networks within and outside the organization
- Develop a flexible strategy for Drug Substance delivery
- Ensure manufacturing compliance with policies and regulations
- Coordinate activities across manufacturing and engineering
- Design and operationalize new product introductions
- Manage resource allocation and organizational costs
- Contribute to integrated planning of clinical supply
- Implement continuous improvement initiatives
Work Experience
Education
Languages
- Sanofi International AGFull-timeOn-siteSeniorRisch-Rotkreuz
- Merck & Co., Inc.
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Sr Director Drug Substance Facility Lead(m/w/x)
As a Senior Director Drug Substance Facility Lead, you will oversee the production of high-quality biologics, ensuring compliance and optimizing processes while fostering a culture of safety and accountability. This role involves strategic planning, resource management, and driving continuous improvement initiatives to enhance operational efficiency.
Requirements
- Bachelor’s degree in biology, chemical engineering, or related discipline or equivalent
- At least 12 years of experience in GMP manufacturing in pharmaceutical or biotech industry
- Master’s degree with at least 10 years of experience in relevant position
- Experience in commercial drug substance manufacturing using mammalian cell culture
- Experience in upstream and downstream processing
- Experience in tech transfer and leading cross-functional teams
- Working knowledge of cGMP regulations across multiple markets
- Demonstrated supervisory and leadership skills
- Experience as manager of managers
- Excellent oral and written communication skills in English
- Qualification and training in economics and LEAN management
- Accountability and budget management skills
- Business performance management and planning skills
- Client relationship building and customer-focused approach
- Data-driven decision making and continuous improvement
- Leadership and people leadership skills
- Manufacturing quality control and scale-up experience
- New product introduction process experience
- Process engineering skills
Tasks
- Oversee drug substance production operations
- Provide functional leadership in production support areas
- Ensure compliance with cGMP, FDA, and quality standards
- Implement and monitor safety protocols
- Create production plans with cross-functional teams
- Optimize resource allocation for cost-effective practices
- Identify and implement process improvements
- Establish governance structures for site performance
- Communicate BPR&D and site strategies to employees
- Drive accountability across cross-functional teams
- Set and monitor key performance targets
- Develop organizational culture focused on empowerment and inclusion
- Lead recruitment, training, and performance management
- Establish succession plans for operations
- Build strong networks within and outside the organization
- Develop a flexible strategy for Drug Substance delivery
- Ensure manufacturing compliance with policies and regulations
- Coordinate activities across manufacturing and engineering
- Design and operationalize new product introductions
- Manage resource allocation and organizational costs
- Contribute to integrated planning of clinical supply
- Implement continuous improvement initiatives
Work Experience
Education
Languages
About the Company
Merck & Co., Inc.
Industry
Pharmaceuticals
Description
Das Unternehmen agiert als weltweit zuverlässiger Hersteller und Lieferant von Biopharmazeutika und beliefert Kunden und Patienten mit qualitativ hochwertigen Produkten.
- Sanofi International AG
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Full-timeOn-siteSeniorRisch-Rotkreuz - Merck & Co., Inc.
Assoc. Dir., Engineering(m/w/x)
Full-timeOn-siteSeniorLuzern - Sanofi International AG
Head of M&S SpeCare Strategy – Global Launch Center(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - MSD Animal Health GmbH
Associate Director, Animal Health, Global Quality Technical and Compliance Team(m/w/x)
Full-timeOn-siteManagementfrom 82,400 / yearLuzern - Sanofi International AG
Head, Launch Acceleration & Regulatory Enablement - Global Launch Center(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz