1. Why join us?
The Advanced Therapies Platform at Sant Joan de Déu Barcelona Children’s Hospital is a state-of-the-art infrastructure dedicated to the development and manufacturing of Advanced Therapy Medicinal Products (ATMPs), with a strong focus on pediatric applications.
The Platform spans over 1,280 m², including ATMP research and development areas, GMP manufacturing and cryopreservation facilities, and administrative spaces. The manufacturing area includes four certified GMP cleanrooms and is focused on the production of cell and gene therapies such as CAR-T and dendritic cells, as well as the manufacturing of lentiviral vectors (LVV). The Platform collaborates with both academic institutions and pharmaceutical companies at national and international levels.
The Advanced Therapies Platform is part of leading national and international networks specialized in ATMPs and drives cutting-edge research and manufacturing projects. It brings together a multidisciplinary team of biologists, biotechnologists, physicians, pharmacists, technicians, and researchers, ensuring a highly stimulating, comprehensive, and collaborative work environment.
Our mission is to transform research into real therapies that save lives. If you are looking for a role where your technical expertise has a direct and tangible impact on patient health, this is your place.
1. Position Mission
To lead and coordinate GMP manufacturing activities for advanced therapies and lentiviral vectors, ensuring regulatory compliance, product quality, and operational efficiency, and contributing to patient access to innovative therapies, particularly in the pediatric setting.
The Production Manager will oversee a team of production technicians, working in close collaboration with Quality Assurance (QA) and Quality Control (QC) departments, and in coordination with Platform leadership to ensure proper execution of operations within the established regulatory and organizational framework.
1. Key Responsibilities
Production Management
* Supervise and execute manufacturing activities in classified cleanrooms (Grade B/C depending on the process).
* Plan and coordinate production campaigns for cell and gene therapies (including CAR-T) and other ATMPs.
* Plan and coordinate lentiviral vector (LVV) production campaigns.
* Oversee and execute technology transfer processes from external entities (academic or industrial) into the GMP environment.
* Lead the development and implementation of new manufacturing processes.
* Work closely with QC, QA, and the Qualified Person (QP) to ensure operational continuity.
Quality and Regulatory Compliance
* Ensure proper execution and review of batch records and all associated GMP documentation.
* Proactively manage deviations, out-of-specification results (OOS), CAPAs, and change controls.
* Actively participate in regulatory audits and inspections (e.g., AEMPS, EMA, FDA).
* Ensure qualification, training, and continuous development of production staff.
Continuous Improvement and Innovation
* Lead technology transfer from R&D laboratories to GMP production.
* Implement continuous improvement initiatives to optimize efficiency and reduce risks and costs.
* Evaluate and integrate new technologies, including automation and closed systems (e.g., CliniMACS Prodigy).
Team Leadership
* Lead, motivate, and develop the production technical team.
* Set clear objectives, evaluate performance, and foster professional development.
* Act as a key interface between the Platform and external partners for manufacturing and technology transfer activities.
Cross-functional Collaboration
* Collaborate closely with clinical, regulatory, pharmaceutical, and research teams, as well as external partners (hospitals, biotech companies, etc.).
DAY SCHEDULE AND CONTRACT:
* The working day will be at 100%, from Monday to Friday with midday break.
* Hours: 8:00h to 16:44h. Performance of on-call and on-site duty.
* Permanent contract.
Mandatory Requirements
* Education: Degree in Pharmacy, Biology, Biotechnology, or a related scientific discipline.
* Professional Experience: Proven experience in GMP manufacturing environments.
* Technical Expertise: Hands-on experience in cell and/or gene therapy production, including work in classified cleanrooms.
* Team Management: Previous experience leading and managing technical teams.
* Regulatory Knowledge: Strong knowledge of EU-GMP regulations (EudraLex Volume 4) and ATMP-specific legislation (Regulation (EC) No 1394/2007).
* Languages: English level B2–C1 (required for technical documentation, audits, and international collaboration).
Preferred Qualifications
* Additional Education: PhD or postgraduate specialization in Advanced Therapies (ATMPs).
* Specific Experience: Direct experience in CAR-T and/or other ATMP manufacturing and/or viral vector (LVV) production.
* Inspections: Experience in regulatory inspections (AEMPS, EMA, etc.).
* Technology: Practical knowledge of automated cell processing systems (e.g., CliniMACS Prodigy).
* Environment: Experience in technology transfer and/or work in hospital or academic settings.
* R&D: Experience in leading or participating in ATMP research and development projects.
1. Benefits
* Professional Development: Continuous training opportunities and participation in national and international conferences.
* Meaningful Impact: Direct involvement in cutting-edge projects with immediate clinical application.
* Contract: Permanent.
* Flexible Compensation Plan.
DOCUMENTS TO SUBMIT:
To apply for this job and attach your resume, click the "Apply" button on this screen.
The application period is 30 calendar days from the date of publication of this announcement.
We encourage you to focus your application on your experience and skills. It is not necessary to include a photograph, gender, or age.
Esplugues de Llobregat, April 22, 2026