Roche Diagnostics Int. AG
People Leader & Assay Architect(m/w/x)
Vollzeit
Keine Angabe
Risch-Rotkreuz
ME
Merck & Co., Inc.12 Stunden
Sr Director Drug Substance Facility Lead(m/w/x)
Management
Vollzeit
Keine Angabe
Luzern
Nejo KI-Zusammenfassung
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.
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Anforderungen
- •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
Bachelor-Abschluss
ODER
Master-Abschluss
ODER
Abgeschlossene Berufsausbildung
Berufserfahrung
10–12 Jahre
Deine Aufgaben
- •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
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Merck & Co., Inc. erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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