​Mantell Associates is proud to be partnered for the past 2 years with a leading Contract Development and Manufacturing Organization specializing in the field of Cell and Gene Therapy. The cutting-edge technologies and expertise enable the development and production of advanced therapies that have the potential to revolutionize the treatment of various diseases. As they continue to expand their manufacturing, we are now seeking a dynamic and experienced professional to join us as the Head of Manufacturing & Technical Operations.

You will play a critical role in overseeing and managing the technical aspects of our operations related to cell and gene therapy, specifically focusing on viral vectors. You will lead a team of talented scientists and engineers to ensure efficient and compliant production processes, and you will be responsible for driving innovation, optimizing operations, and ensuring high-quality deliverables.

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Responsabilities:

• Ability to lead scenario planning, options analysis, and risk management activities

• Technical Leadership: Provide strategic direction and technical leadership in the development, scale-up, and optimization of viral vector manufacturing processes and associated technologies

• Manufacturing Process Optimization: Continuously evaluate and enhance manufacturing processes to increase efficiency, productivity, and cost-effectiveness, while maintaining strict compliance with regulatory guidelines

• Cross-Functional Collaboration: Collaborate closely with cross-functional teams, including Research and Development, Quality Assurance, Supply Chain, and Project Management, to ensure seamless integration and successful execution of projects

• Risk Management: Identify potential risks and implement risk mitigation strategies to ensure uninterrupted production and delivery of high-quality products

• Documentation and Reporting: Ensure accurate and timely documentation of all technical activities and prepare comprehensive reports for senior management

• Quality Assurance and Compliance: Ensuring compliance with regulatory guidelines and maintaining high-quality standards is crucial in the field of cell and gene therapy. As the head of manufacturing and technical operations, you would establish and maintain robust quality systems and processes to ensure compliance with applicable regulations and industry standards. You would oversee the implementation of quality control measures, perform regular audits, and collaborate with regulatory authorities to ensure adherence to regulatory requirements

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Qualifications:

• At least over 5 years of hands-on experience at variant levels of managing roles in pharma/biotech in a technical operations/ Manufacturing role, including supervising production management of more than one facility

• Experience in regulatory submission and clinical approval (or IND) is required, experience in BLA or MAA is a plus

• Experience as a manager in pharma/biotech in a technical operations / QA / Manufacturing role and one or more cell and gene therapy modalities (e.g. viral vectors, plasmids, mRNA)

• Experience managing client relationships

• Experience with CDMO manufacturing/service agreement contracting

• Experience supporting biologics CMC regulatory submissions

• Experience in working with multidisciplinary teams

• Highly organized and capable of leading/pursuing multiple projects independently

• Experience with GMP requirements and interfacing with QA (Quality Assurance) and technical teams

• Experience in planning and qualifying a new facility

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Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information get in contact with Sofia Furlan at +44 203 3854 7728 or sofia.furlan@mantellassociates.com.