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Vice President of Manufacturing

4 months ago

Fort Dodge, United States Global Life Science Hub Full time

Global Life Science Hub is partnered with a niche, specialist biopharmaceutical company offering next-generation drug delivery technologies and an advanced pipeline of oral and biosimilar drugs. They aim to improve patient outcomes through innovative drug delivery technologies and therapeutic solutions. Following a recent FDA approval, they seek an experienced and visionary Senior Director/Vice President of Manufacturing to oversee their manufacturing operations and drive their supply chain strategies. The ideal candidate will have a strong background in manufacturing and a proven track record of successfully managing complex manufacturing processes while ensuring quality and regulatory standards adherence. This role requires a strategic thinker who can effectively optimize manufacturing operations, foster innovation, and lead cross-functional teams to deliver high-quality products on time and within budget. Responsibilities: Develop and execute the overall manufacturing strategy in alignment with the company's goals and objectives, with a particular focus on biologics production and supply chain management. Provide strong leadership and guidance to the manufacturing team, fostering a culture of continuous improvement, collaboration, and accountability. Oversee all aspects of biologics manufacturing operations, including process development, technology transfer, scale-up, and commercial production, while ensuring compliance with cGMP regulations and industry standards. Collaborate with R&D, Quality Assurance, Regulatory Affairs, and other relevant departments to ensure seamless integration of manufacturing activities across the organization. Lead efforts to optimize manufacturing processes, improve efficiencies, and reduce costs while maintaining high-quality standards and meeting production targets. Drive the implementation and adoption of advanced manufacturing technologies and automation systems to enhance productivity, reduce cycle times, and increase manufacturing capacity. Establish and maintain effective relationships with key suppliers and contract manufacturing organizations (CMOs) to ensure reliable and cost-effective supply of raw materials, intermediates, and finished products. Collaborate with the Quality Assurance team to establish and maintain a robust quality management system, ensuring compliance with applicable regulations and industry best practices. Develop and monitor key performance indicators (KPIs) to track manufacturing performance, identify areas for improvement, and drive operational excellence initiatives. Stay abreast of industry trends, technological advancements, and regulatory changes related to biologics manufacturing and supply chain management, and proactively recommend strategies to maintain a competitive edge. Experience/Qualifications: Bachelor's degree in a scientific or engineering discipline; advanced degree preferred. Minimum of 10 years of progressive leadership experience in biologics manufacturing, with a strong focus on biopharmaceuticals. Extensive knowledge of cGMP regulations and quality systems applicable to biologics manufacturing. Proven track record of successfully managing and optimizing biologics manufacturing processes, including process development, scale-up, and commercial production. Demonstrated experience in implementing advanced manufacturing technologies and automation systems in a biologics manufacturing environment. Strong leadership and team-building skills, with the ability to effectively motivate and develop high-performing teams. Excellent problem-solving and decision-making abilities, with a strategic mindset and the ability to think critically in complex situations. Outstanding communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams, senior management, and external partners. Demonstrated ability to manage multiple priorities and projects simultaneously, while ensuring timely completion and adherence to budgetary constraints. Knowledge of biologics supply chain management and experience in establishing and maintaining relationships with suppliers and contract manufacturing organizations (CMOs) is highly desirable. Apply:The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.If you're interested, please apply below. If this position doesn't interest you, please visit our website for a list of more vacancies - www.glshub.com