Director of Manufacturing

Job Description: Director of Manufacturing – Human iPSC Derived Cells

As the Director of Manufacturing for our innovative company specializing in the production of human iPSC-derived cells for drug discovery, research, and cell therapy, you will play a pivotal role in ensuring the quality, efficiency, and scalability of our manufacturing operations. This position offers a unique opportunity to lead a dynamic team, shape the future of bioprocessing, and contribute to advancements in the healthcare and life sciences industries.

Responsibilities:

• Manufacturing Strategy and Leadership:
• Develop and execute a comprehensive manufacturing strategy that aligns with the company's objectives and supports growth and innovation.
• Lead a team of manufacturing professionals to achieve production targets, maintain quality standards, and improve operational efficiency.
• Oversee all aspects of the manufacturing process, including cell culture, expansion, differentiation, and quality control.
• Quality Control and Compliance:
• Implement and maintain rigorous quality control processes to ensure the consistency and safety of iPSC-derived cell products.
• Ensure compliance with regulatory standards and guidelines relevant to the production of cell therapies and biologics.
• Collaborate with regulatory affairs and quality assurance teams to support regulatory submissions and inspections.
• Process Improvement and Innovation:
• Identify opportunities for process optimization and innovation to increase production yields and reduce costs.
• Evaluate and implement advanced bioprocessing techniques and technologies to enhance manufacturing capabilities.
• Collaborate with R&D and engineering teams to develop and scale-up new manufacturing processes.
• Resource Management:
• Manage the allocation of resources, including personnel, equipment, and materials, to meet production demands.
• Develop and monitor production schedules, ensuring timely delivery of high-quality iPSC-derived cell products to customers.
• Team Development:
• Recruit, train, and develop a skilled manufacturing team, fostering a culture of continuous improvement, accountability, and safety.
• Provide leadership and mentorship to team members, promoting professional growth and expertise in biomanufacturing.
• Cost Management:
• Establish and manage the manufacturing budget, controlling expenses while maintaining product quality.
• Identify cost-saving opportunities and implement strategies to optimize the cost-effectiveness of manufacturing operations.
• Collaboration and Communication:
• Collaborate with cross-functional teams, including research and development, quality assurance, and sales and marketing, to ensure alignment of manufacturing activities with company goals.
• Communicate regularly with senior management to provide updates on manufacturing performance, challenges, and strategic recommendations.

Qualifications:

• A minimum of 10 years of experience in a leadership role within biopharmaceutical manufacturing, with a focus on cell therapies or biologics.
• Bachelor's or advanced degree in a relevant scientific or engineering discipline.
• Strong knowledge of cGMP regulations and industry best practices related to biomanufacturing.
• Proven track record of successful process optimization and implementation of advanced bioprocessing technologies.
• Exceptional leadership and team management skills, with the ability to build and motivate high-performing teams.
• Experience in managing manufacturing budgets and resources effectively.
• Strong problem-solving skills and a continuous improvement mindset.
• Excellent communication and collaboration abilities, with the capacity to work effectively with cross-functional teams and communicate manufacturing strategies and outcomes to executive leadership.

Join us in advancing the field of cell therapy and biomanufacturing by leading our manufacturing operations and ensuring the consistent production of high-quality iPSC-derived cell products.