Head of Production CCRM Nordic

4 days ago

Gothenburg, Västra Götaland, Sweden CCRM Nordic AB (svb) Full time 1,200,000 - 1,500,000 per year

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.

  • CQV Lead, CCRM Nordic

    4 days ago

    Gothenburg, Västra Götaland, Sweden CCRM Nordic AB (svb) Full time 900,000 - 1,200,000 per year

    Looking for an exciting opportunity to contribute to the development of next-generation cell and gene therapies and to Sweden's ambition of becoming a leader in Advanced Therapy Medicinal Products (ATMPs)?Consider applying for the CQV Lead role at CCRM Nordic.About CCRM NordicCCRM Nordic is a national infrastructure for the commercialization of advanced...

  • Head of Rewards Nordics

    4 days ago

    Gothenburg, Västra Götaland, Sweden Hudson Nordic Full time 90,000 - 120,000 per year

    On behalf of Nouryon, we are now looking for aHead of Rewards NordicsLocation: GothenburgShape the future of Total Rewards in a global leader. At Nouryon, our global team of Changemakers takes positive action every day, to reach higher collectively and individually. We create innovative and sustainable solutions for our customers to answer society's needs...

  • Site & Production Manager, Arendal/Gothenburg

    4 days ago

    Gothenburg, Västra Götaland, Sweden Hudson Nordic Full time 80,000 - 120,000 per year

    We are seeking an experienced and highly motivated manager to lead Arendal SSC unit. In this role you are responsible for leading the Arendal site with approximately 120 employees including the important areas safety and environment. Becoming part of the SSAB family means joining a journey. A journey that we believe is essential for the sustainability of...

  • Head of Sales

    4 days ago

    Gothenburg, Västra Götaland, Sweden Hudson Nordic Full time 120,000 - 240,000 per year

    On behalf of Manta Marine Technologies, we are now looking for aHead of SalesManta Marine Technologies (MMT) offers a comprehensive portfolio of cutting-edge technologies to enable a greener maritime industry. These range from Vessel Optimization solutions — such as FuelOpt, Route Pilot AI and Fleet Analytics — to Turnkey Shore Power Solutions, VFDs and...

  • Head of Sales

    4 days ago

    Gothenburg, Västra Götaland, Sweden Hudson Nordic Full time 1,200,000 - 2,400,000 per year

    On behalf of Manta Marine Technologies, we are now looking for aHead of SalesManta Marine Technologies (MMT) offers a comprehensive portfolio of cutting-edge technologies to enable a greener maritime industry. These range from Vessel Optimization solutions — such as FuelOpt, Route Pilot AI and Fleet Analytics — to Turnkey Shore Power Solutions, VFDs and...

  • Head of Sales to SmartCraft SME Construction

    4 days ago

    Gothenburg, Västra Götaland, Sweden Committo Full time 120,000 - 180,000 per year

    Join SmartCraft's journey of growth and transformationSmartCraft is a fast-growing Nordic SaaS company providing digital solutions to the construction industry. Within the business area SME Construction, which today includes Bygglet (Sweden) and Kvalitetskontroll (Norway), we are now seeking a Head of Sales to drive our next phase of commercial growth.This...

  • Digital Product Manager

    4 days ago

    Gothenburg, Västra Götaland, Sweden Hudson Nordic Full time 550,000 - 850,000 per year

    On behalf of Manta Marine Technologies, we are now looking for aDigital Product ManagerSince 2010, Manta Marine Technologies has been at the forefront of maritime emissions reduction, working closely with ship-owners, yards, and naval architects as partners in our effort to drive the change towards sustainable shipping. Today, Manta Marine offers a...

  • Nelly - Head of Studio & Creative Production

    4 days ago

    Gothenburg, Västra Götaland, Sweden Infinity HR AB Full time 500,000 - 1,200,000 per year

    Kan du konsten att kombinera kreativitet och struktur? Har du därtill ett starkt visuellt öga och är van vid att leda andra? Till NELLY söker vi nu en Head of Studio & Creative Production – en pulserande roll där du blir ansvarig för den kreativa plats där alla produkter i sortimentet fotas och presenteras. Vår helt nybyggda studio står färdig...

  • Head of Service

    2 weeks ago

    Gothenburg, Västra Götaland, Sweden Saab Full time 120,000 - 240,000 per year

    Saab is a place where teamwork makes things fly. Literally. Join us and experience our supportive and friendly workplace.Are you a communicative and collaborative leader who wants to drive development and success on all levels – from business to employees? We are looking for a manager to lead one of our departments and to join our product unit in an...

  • Manager Sales Nordics

    4 days ago

    Gothenburg, Västra Götaland, Sweden Planon Full time

    We are transforming how organizations manage their buildings and workplaces through innovation, sustainability, and smart technology. As the Head of Sales for the Nordics, you will lead a talented team and play a key role in expanding our presence across the region. This is a great opportunity to combine leadership, strategy, and client success within a...