Xintela is a rapidly developing biomedical company developing innovative therapies in stem cell therapy and antibody-based cancer therapy. The company has a current focus on two areas of large unmet medical need for new and better treatments: osteoarthritis and aggressive cancers. The company is located in Lund, Sweden and for more information please visit www.xintela.se
Xintela is looking for a Head of Manufacturing/ CMC to help lead the company's CMC strategy in the next stage of its growth. The position reports to the CEO and will form part of the company's senior management team. The Head of Manufacturing/ CMC will be responsible for all aspects of manufacturing of Xintela's proprietary mesenchymal stem cell therapies for pre-clinical and clinical trials in Xintela's GMP facility. This expansive role encompasses responsibility for all aspects of the Xintela GMP manufacturing facility, including technical product development, Process Development, Scale up, Quality, Manufacturing, CMC Regulatory and GMP facility management. The incumbent will also be responsible for managing the production team, procurement of equipment and materials, maintenance of clean room procedures and SOPs; qualification/validation of equipment, training of staff.
The Head of Manufacturing/ CMC will also work in close collaboration with the various different functions in the company including R&D, Clinical, Regulatory Affairs and Business Development.Main Responsibilities:
Experience and Qualifications:Essential:
- Lead Process Development activities to ensure reproducible, compliant products for patients aligned with all relevant regulatory agency guidance
- Lead all Product Manufacturing Scale up activities to meet company plans and timelines
- Lead all manufacturing activities in compliance with relevant cGMP and ICH requirements
- Ensure all manufacturing and CMC activities are aligned with the company strategy and plans
- Leading the assessment of any out of spec or product deviation investigations and the institution of corrective actions and corporate learnings
- Responsible for CMC Regulatory activities and compliance
- Responsible for the smooth running and maintenance of the GMP manufacturing facility, including routine maintenance, compliance and SOPs
- Responsible for all fill/ finish activities to facilitate delivery of safe, effective therapies to patients
- Responsible for ensuring product transport & Logistics systems and suppliers
- Lead, motivate and develop the Manufacturing Team
- Develop and implement operating plans to achieve objectives
- At least a Master of Science in a relevant field.
- Proven experience in key aspects of GMP CMC relevant to the role
- Experience of cell culture and clean room techniques
- Demonstrated understanding of the requirements for GMP CMC manufacture, including development and use of relevant SOPs, QC requirements and a QMS.
- Fluent in English with excellent communication skills
- A proven understanding of the broader business, clinical, regulatory and strategic aspects of developing a therapy
- A proven positive 'hands on' approach to pitching in and getting things done
- Manufacturing experience with ATMP or Biologic therapies
- Experience of leading teams in Process Development and Scale up
- Led the development and submission of CMC documentation for all stages of pre-clinical and clinical development
- Fluent in Swedish
- Experience of working in a small biotech company
Xintela is a small, tightly knit team of individuals working towards the development of truly innovative life-changing therapies for patients. We look forward to having you join us in our mission. We welcome your application as soon as possible and no later than 16th of October 2020. For further information please contact our recruitment consultant Monika Kumlin Larsson at STRETCHHR +46 706 291853.