Sr Director Drug Substance Facility Lead(m/w/x)

Beschreibung

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.

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

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