A6- Director/a de la Unitat de Teràpies Avançades

About the Unit / Group

The Sant Pau Research Institute has established the Advanced Therapies Unit (UTA) to promote research in this field, expand GMP-compliant manufacturing capacity, and facilitate the translation of these therapies into clinical practice.

This unit represents a strategic commitment to provide research groups with the resources, capabilities, and support needed to develop advanced therapy projects and to offer specialized services to both public and private sectors.

The Unit currently includes cleanroom facilities and plans to incorporate state-of-the-art infrastructure to meet the highest quality and manufacturing standards, positioning the Institute as a leading centre in Europe.

UTA already hosts several active Advanced Therapy Medicinal Product (ATMP) projects, including academic CAR-T clinical trials.

The selected candidate will play a key role in leading both the Unit and the Technical Direction of the facility.

Essential requirements

• Minimum required qualification: Higher university degree in Pharmacy, Medicine, Veterinary Medicine, Chemistry, Pharmaceutical Chemistry and Technology, Biology or another equivalent qualification appropriate to the position.
• Proven 5 years of experience in one of the following areas: technical management, administration or supervision of cleanroom facilities or pharmaceutical manufacturing environments, preferably in regulated contexts; or, team management and coordination of technical and operational activities; or, Technical Direction in pharmaceutical manufacturing facilities, cleanrooms or similar regulated environments.
• Proven training and/or experience in Advanced Therapy Medicinal Products (ATMPs), especially in cell and gene therapy.
• Oral and written knowledge of both official languages of Catalonia. Level C of Catalan or, failing that, the selected candidate must demonstrate or commit to acquiring, within a period not exceeding one year, an adequate command of both official languages in Catalonia.
• Advanced level of English.
• Advanced knowledge of office tools (Excel, Word, Power Point, etc.). Skills will be valued
• Strong knowledge of ATMP manufacturing processes
• Minimum two years’ experience in quality control and analysis
• GMP training and experience
• Knowledge of ATMP-specific GMP regulations (Eudralex Vol. 4, Part IV)
• Biosafety training
• Experience with AEMPS and regulatory inspections
• Experience in cleanroom environments
• Experience in GMP facility setup or expansion
• Analytical, organizational, and teamwork skills
• Experience in project development and collaboration

Functions

• Lead the setup and strategic development of the UTA
• Act as Technical Director of the facility
• Oversee GMP operations and facilities
• Manage deviations, CAPAs, and continuous improvement
• Ensure compliance in manufacturing and quality control
• Batch release responsibility
• Support GMP certification expansion
• Manage Quality Management System
• Oversee Unit resources
• Define growth strategy
• Promote collaborations and projects
• Define service model
• Institutional representation Offered
• Permanent contract.
• Annual working time of 1,627.50 hours (37.5 hours/week).
• Salary according to collective agreement.
• Research Group: Advanced Therapies Unit Documentation and deadline for submission Interested parties should preferably deliver the documentation (1) in PDF, by e-mail to the Management of the Santa Creu i Sant Pau Hospital Research Institute Foundation, address seleccio@recercasantpau.cat , indicating the reference 2026/041: (1) Application letter and updated Curriculum Vitae and signed Data Processing Authorization** At the request of the Santa Creu i Sant Pau Hospital Research Institute Foundation, the candidates must present the documentation accrediting the merits mentioned in the curriculum vitae.