A biotech manufacturing company is seeking a strong General Manager to oversee operations and drive the development and commercialization of advanced therapies.
Major Duties and Responsibilities:
Oversee all operational aspects of advanced therapies, including:
Source material collection
Cell therapy testing
Logistics
Biomanufacturing
Quality assurance
Ensure coordination supports the development and commercialization of advanced therapies.
Manage site activities related to product development and commercial manufacturing, ensuring:
Quality standards are met
Delivery metrics are achieved
Revenue goals are attained
Regulatory compliance is maintained
Implement processes to improve cost-effectiveness and operational efficiency.
Plan for scalability in biomanufacturing to ensure successful market entry for advanced therapies.
Collaborate with support units to ensure effective operational management and cross-functional coordination.
Provide regular updates to the board of directors and support the Chief Operating Officer as needed.
Develop and implement staff development programs focused on career progression and engagement.
Foster cross-functional collaboration to streamline operations and support successful product commercialization.
Deliver excellent customer service by understanding internal and external customer needs.
Prepare pitches and presentations to ensure team alignment in communicating core value propositions.
Establish robust risk assessment and quality control systems, ensuring compliance with cGMP and other regulations.
Manage a team of 5-9 directly, overseeing a larger group of over 100 employees, including:
Interviewing, hiring, and training
Perform other duties as assigned.
Skills and Requirements
Bachelor's Degree from an accredited institution in a relevant field
Preferred: Master's Degree from an accredited institution.
Minimum of 15 years in the industry with a proven track record in sterile and aseptic product market introductions
At least 10 years in managerial roles
Experience in the pharmaceutical or biotechnology sectors, with a history of increasing responsibility.
Familiarity with manufacturing processes within a GMP environment and applicable regulations.
Strong organizational, customer service, and troubleshooting skills.
Ability to apply advanced mathematical concepts, including:s
Excellent management, leadership, and communication skills, including
Capable of operating vehicles in various weather conditions.
Proficient computer skills, with excellent written and oral communication abilities.
Strong analytical skills to determine root causes and assess risk elements while considering alternative actions.