Sanofi International AG
Global Head of Strategic Projects and Portfolio Management EM&S – Global Launch Center(m/w/x)
Full-timeOn-siteSenior
Risch-Rotkreuz
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MEMerck & Co., Inc.
Sr Director Drug Substance Facility Lead(m/w/x)
Luzern
Full-timeOn-siteManagement
Nejo AI Summary
Directing commercial biopharmaceutical production, including mammalian cell culture and upstream/downstream processing, at a global biopharma manufacturer. 12+ years GMP manufacturing experience in pharma/biotech, with mammalian cell culture, required. On-site leadership role, fostering cross-functional team collaboration.
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
- 10 - 12 years
Education
- Vocational certificationOR
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Merck & Co., Inc. and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
- Merck & Co., Inc., Rahway, NJ, USA
Responsible Person Dir Quality Assurance(m/w/x)
Full-timeOn-siteSeniorWerthenstein - Sanofi International AG
Head of M&S SpeCare Strategy – Global Launch Center(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Sanofi International AG
Head of M&S Specialty Care Network Strategy – Global Launch Center(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Sanofi International AG
Head, Launch Acceleration & Regulatory Enablement - Global Launch Center(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz
MEMerck & Co., Inc.
Sr Director Drug Substance Facility Lead(m/w/x)
Luzern
Full-timeOn-siteManagement
Nejo AI Summary
Directing commercial biopharmaceutical production, including mammalian cell culture and upstream/downstream processing, at a global biopharma manufacturer. 12+ years GMP manufacturing experience in pharma/biotech, with mammalian cell culture, required. On-site leadership role, fostering cross-functional team collaboration.
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
- 10 - 12 years
Education
- Vocational certificationOR
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Merck & Co., Inc. and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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.
Not a perfect match?
- Sanofi International AG
Global Head of Strategic Projects and Portfolio Management EM&S – Global Launch Center(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Merck & Co., Inc., Rahway, NJ, USA
Responsible Person Dir Quality Assurance(m/w/x)
Full-timeOn-siteSeniorWerthenstein - Sanofi International AG
Head of M&S SpeCare Strategy – Global Launch Center(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Sanofi International AG
Head of M&S Specialty Care Network Strategy – Global Launch Center(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Sanofi International AG
Head, Launch Acceleration & Regulatory Enablement - Global Launch Center(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz