Hospitals and Health Care
Active

Francisco S

Director of Production and Development

About Me

I am a highly experienced leader in the field of Advanced Therapy Medicinal Products (ATMPs), with over a decade of expertise spanning scientific research, regulatory compliance, and operational management. I have held senior roles in renowned organizations, where I led multidisciplinary teams, oversaw cell and tissue banking operations, coordinated several ATMPs development projects and ensured adherence to ISO 9001, AABB, GMP, and GDP standards. My background combines hands-on laboratory management with strategic business development, focusing on continuous process improvement, risk-based thinking, and stakeholder engagement. I have successfully managed budgets, optimized resources, and implemented quality control programs for cryopreserved products and ATMPs. My regulatory knowledge is complemented by direct experience with EMA, including scientific advice procedures.

Experience

Seniority LevelDirector
Years of Experience10-15 years
Current StatusActive

Skills

Core skills1
Languages2

Skills

>Leadership & Decision-Making: Ability to guide teams, make strategic decisions, and drive operational efficiency. >Regulatory & Compliance Knowledge: Familiarity with ISO 9001, AABB standards, GMP and GDP, and other legal regulations related to cryopreservation, quality control, pharmaceutical development and data protection. >Analytical & Problem-Solving Skills: Ability to monitor quality control programs, assess risks, and implement corrective measures. >Project & Resource Management: Experience in coordinating laboratory activities, managing budgets, and optimizing resources. >Communication & Stakeholder Management: Strong ability to collaborate with multidisciplinary teams, suppliers, and regulatory authorities. >Technical Expertise: Knowledge of laboratory processes, cryopreservation, tissue and cell banking procedures and ATMP development. >Continuous Improvement & Innovation: Commitment to improving processes, identifying new business opportunities, and ensuring compliance with evolving regulations.

Languages

English
Portuguese

Services