Head of Production CCRM Nordic

5 days ago

Göteborg, Sweden CCRM Nordic AB (svb) Full time

General Description of role: The Head of Production will manage all aspects of GMP operations for ATMPs, ensuring compliance with regulatory requirements and quality standards and efficient execution of manufacturing activities. The role will manage day-to-day GMP activities and lead the GMP team to ensure efficient and compliant operations. This role will involve coordination of technology transfer and cross-functional collaboration to meet client and clinical development timelines. The ideal candidate will have expertise in vector manufacturing, scalable cell and gene therapy technologies and experience leading multi-disciplinary teams. Tasks and Responsibilities: · Oversee and manage GMP operations including vector and cell therapy manufacturing, to ensure compliance with regulatory guidelines and internal quality standards within CCRM Nordic. · Direct establishment of LVV manufacturing platform within CCRM Nordic GMP facility. · Direct the development and transfer of high-yield vector production platforms into GMP manufacturing, ensuring scalability and compliance with GMP standards. · Lead the implementation of scalable and robust bioprocessing strategies for both 2D and 3D culture systems in cell and gene therapy (CGT) manufacturing. · Schedule and manage manufacturing activities for multiple clients within the GMP facility. · Monitor and report on GMP performance metrics and trends, recommending improvements and changes as needed. · Review and assess quality incidents and perform risk assessments for process and manufacturing activities, supporting process performance qualification. · Guide and support the team in the development of critical process documentation and provide data to support regulatory submissions and technical reports for clients. · Interact with academic and industry groups to provide expertise in scaling, de-risking, and automating processes suitable from early-stage development through to commercial manufacturing. · Ensure effective collaboration with therapy developers to support the seamless transfer of technology and the delivery of manufacturing activities. · Line manage, mentor, and develop a matrixed team of scientists, associates, and operators. Education and Work Requirements: · Advanced degree or equivalent experience in Bioprocessing, Biochemical Engineering, or a related field. · Extensive experience in GMP management with a focus on bioproduction or ATMPs, minimum 5 years. · Strong leadership and team management skills, with experience in staff recruitment, coaching, and development. · Demonstrated experience in technology transfer and process scaling, with a focus on automation and de-risking strategies. · Familiarity with regulatory standards and quality systems related to GMP manufacturing for ATMPs. · Proven expertise in CMC activities, particularly in the design and optimization of scalable manufacturing processes. · Strong knowledge of QBD principles and DoE methodology in experimental design. · Experience supporting manufacturing comparability studies and contributing to client-driven regulatory submissions (e.g., IND, IMPD). · Experience with clinical material supply chain management and logistics. · Excellent communication skills, with the ability to collaborate effectively with cross-functional teams, CDMO partners, and external stakeholders.

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