Director of Manufacturing

  • Beachwood
  • Trailhead Biosystems
<strong>Job Description: Director of Manufacturing - Human iPSC Derived Cells</strong> <br><br>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. <br><br><strong>Responsibilities:</strong> <br><ul><li><strong>Manufacturing Strategy and Leadership:</strong> </li><li>Develop and execute a comprehensive manufacturing strategy that aligns with the company's objectives and supports growth and innovation. </li><li>Lead a team of manufacturing professionals to achieve production targets, maintain quality standards, and improve operational efficiency. </li><li>Oversee all aspects of the manufacturing process, including cell culture, expansion, differentiation, and quality control. </li><li><strong>Quality Control and Compliance:</strong> </li><li>Implement and maintain rigorous quality control processes to ensure the consistency and safety of iPSC-derived cell products. </li><li>Ensure compliance with regulatory standards and guidelines relevant to the production of cell therapies and biologics. </li><li>Collaborate with regulatory affairs and quality assurance teams to support regulatory submissions and inspections. </li><li><strong>Process Improvement and Innovation:</strong> </li><li>Identify opportunities for process optimization and innovation to increase production yields and reduce costs. </li><li>Evaluate and implement advanced bioprocessing techniques and technologies to enhance manufacturing capabilities. </li><li>Collaborate with R&D and engineering teams to develop and scale-up new manufacturing processes. </li><li><strong>Resource Management:</strong> </li><li>Manage the allocation of resources, including personnel, equipment, and materials, to meet production demands. </li><li>Develop and monitor production schedules, ensuring timely delivery of high-quality iPSC-derived cell products to customers. </li><li><strong>Team Development:</strong> </li><li>Recruit, train, and develop a skilled manufacturing team, fostering a culture of continuous improvement, accountability, and safety. </li><li>Provide leadership and mentorship to team members, promoting professional growth and expertise in biomanufacturing. </li><li><strong>Cost Management:</strong> </li><li>Establish and manage the manufacturing budget, controlling expenses while maintaining product quality. </li><li>Identify cost-saving opportunities and implement strategies to optimize the cost-effectiveness of manufacturing operations. </li><li><strong>Collaboration and Communication:</strong> </li><li>Collaborate with cross-functional teams, including research and development, quality assurance, and sales and marketing, to ensure alignment of manufacturing activities with company goals. </li><li>Communicate regularly with senior management to provide updates on manufacturing performance, challenges, and strategic recommendations. </li></ul><br><strong>Qualifications:</strong> <br><ul><li>A minimum of 10 years of experience in a leadership role within biopharmaceutical manufacturing, with a focus on cell therapies or biologics. </li><li>Bachelor's or advanced degree in a relevant scientific or engineering discipline. </li><li>Strong knowledge of cGMP regulations and industry best practices related to biomanufacturing. </li><li>Proven track record of successful process optimization and implementation of advanced bioprocessing technologies. </li><li>Exceptional leadership and team management skills, with the ability to build and motivate high-performing teams. </li><li>Experience in managing manufacturing budgets and resources effectively. </li><li>Strong problem-solving skills and a continuous improvement mindset. </li><li>Excellent communication and collaboration abilities, with the capacity to work effectively with cross-functional teams and communicate manufacturing strategies and outcomes to executive leadership. </li></ul><br>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.