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:
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.
- 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.
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Seniority level
Director -
Employment type
Full-time -
Job function
Manufacturing and Project Management -
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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