Job description
Mantell Associates is partnered with a leading Biologics Contract Development and Manufacturing Organization (CDMO) dedicated to enabling the development and manufacturing of innovative biopharmaceutical products. They are offering state-of-the-art facilities and cutting-edge technology platforms to support clients in advancing their biologic drug candidates from early-stage development through commercialization.
They’re seeking a highly skilled and experienced Director of Manufacturing to oversee and optimise all aspects of biologics manufacturing operations. Would you like to play a pivotal role in advancing the development and production of life-changing biologic therapeutics and lead a team?
Key Responsibilities:
Develop and execute the strategic vision for biologics manufacturing operations, aligning with company goals and client requirements
Provide strong leadership and guidance to the manufacturing team, fostering a culture of collaboration, accountability, and continuous improvement
Drive operational excellence, ensuring adherence to cGMP guidelines, regulatory requirements, and industry best practices
Collaborate with cross-functional teams, including Process Development, Quality Assurance, Supply Chain, and Engineering, to optimize manufacturing processes and resolve any technical challenges
Lead technology transfer activities for new client projects, ensuring seamless integration into the manufacturing facility and successful execution
Serve as a critical point of contact for clients, providing technical expertise, addressing inquiries, and ensuring alignment with project timelines and deliverables
Key Requirements:
Bachelor's degree in a scientific discipline, preferably in Biotechnology, Biochemistry, or a related field. A master’s or PhD is a plus
10+ years of experience in biologics manufacturing within a CDMO or biopharmaceutical company, with a strong understanding of upstream and downstream processes
Demonstrated leadership experience, managing and developing teams in a manufacturing environment
Thorough knowledge of cGMP guidelines, FDA regulations, and industry best practices related to biologics manufacturing
Experience with process optimization, scale-up, and technology transfer from development to manufacturing
Strong analytical and problem-solving skills, with the ability to make informed decisions under pressure
Mantell Associates is a specialist Pharmaceutical and Life Sciences Headhunting firm. For more information on this role, please get in touch with Onur Dilek at onur.dilek@mantellassociates.com.
