Chief Manufacturing Officer

Mantell Associates is currently partnered with a biopharma CDMO with a focus on advanced therapeutics and critical medicines. They are seeking a Chief Manufacturing Officer to join their growing leadership team.

Chief Manufacturing Officer - Responsibilities:

• Responsible for overseeing the company's entire manufacturing function, from production planning and process optimization to ensuring that all products meet regulatory and quality standards
• Play a critical role in scaling production, managing relationships with contract manufacturing organizations (CMOs), and ensuring that manufacturing operations support the company's overall business objectives
• Develop and implement a comprehensive manufacturing strategy that aligns with the company's business objectives and long-term growth plans
• Lead the design and execution of manufacturing processes that ensure efficiency, scalability, and quality
• Collaborate with the supply chain and operations teams to ensure the timely delivery of raw materials and finished products
• Ensure that all manufacturing activities comply with local and international regulatory standards, including Saudi Food and Drug Authority (SFDA) regulations, Good Manufacturing Practices (GMP), and ISO standards
• Work closely with the quality assurance team to implement quality control measures, monitor performance, and ensure that all products meet safety and quality specifications
• Lead efforts to scale manufacturing capabilities in line with the company's growth plans. Optimize manufacturing processes to improve efficiency, reduce costs, and increase output without compromising quality
• Work closely with the Project Management Office (PMO) and Research & Development (R&D) teams to ensure that new products are smoothly transitioned from the development stage to full-scale manufacturing
• Manage relationships with Contract Manufacturing Organizations (CMOs), suppliers, and external partners to ensure that all outsourced manufacturing meets the company's standards for quality, cost, and timelines
• Manage the planning and construction of new manufacturing facilities or the expansion of existing ones, ensuring they are designed for efficiency and future growth
• Lead and mentor the manufacturing team, fostering a culture of accountability, innovation, and continuous improvement. Ensure that the team is trained in the latest manufacturing techniques, technologies, and compliance requirements

Chief Manufacturing Officer - Requirements:

• Extensive experience in biopharmaceutical manufacturing, knowledge of regulatory requirements, and a deep understanding of the operational complexities of scaling in a highly regulated industry
• Bachelor's degree in Engineering, Biotechnology, or a related field
• A Master's degree in Manufacturing, Operations Management, or a related field is preferred
• Minimum of 15 years of experience in biopharmaceutical or healthcare manufacturing, with at least 5 years in a senior leadership role
• Proven track record of scaling manufacturing operations in a highly regulated industry, preferably in biopharmaceuticals or biotechnology
• Deep knowledge of Good Manufacturing Practices (GMP), ISO standards, and regulatory requirements in Saudi Arabia and globally
• Strong expertise in biopharmaceutical manufacturing processes, quality management, and regulatory compliance
• Excellent problem-solving and decision-making skills, with the ability to optimize complex manufacturing operations
• Proven leadership and team management skills, with the ability to mentor and develop high-performance teams
• Proficiency in using manufacturing management software, ERP systems, and data analysis tools