Elaine Ruiz Castro

BIOTECHNOLOGY PROFESSIONAL / QUALITY CONTROL AND MANAGEMENT SPECIALIST

Havana, Cuba | elaine@cim.sld.cu | +53 53017430

PROFESSIONAL PROFILE

Biotechnology professional with over 25 years of experience at the Center for Molecular Immunology (CIM) and international exposure. Specialized in quality management, design and validation of biological assays, cell cultures, and strict compliance with GMP/GLP regulations. Proven track record in leading multidisciplinary teams and successfully defending national and international regulatory audits.

WORK EXPERIENCE

Head of Biological Assays Group | 2012 – 2026, Center for Molecular Immunology (CIM) | Havana, Cuba

Leadership, organizational supervision, and strategic management of the quality control analysts team. Drafting, reviewing, and approving technical reports, validation protocols, and Standard Operating Procedures (SOPs). Active participation and defense during national and international regulatory audits under GMP/GLP standards.

International Technology Transfer Missions (2017 – 2019): Completed 3 international missions aimed at knowledge exchange, technology transfer, and technical standardization of processes.

Quality Management Specialist | 2010 – 2012, Center for Molecular Immunology (CIM) | Havana, Cuba

Design, execution, and validation of in vivo and in vitro analytical assays for batch release. Management, maintenance, and analytical evaluation of master and working cell banks.

Production Specialist / Process Control | 2008 – 2010, Biotech Pharmaceutical Co., Ltd. | Beijing, China

Supervision of large-scale production processes for the generation and scaling of biological inoculums. Ensuring strict compliance with Good Manufacturing Practices (GMP).

Principal Specialist / Biological Processes Technician | 1996 – 2008, Center for Molecular Immunology (CIM) | Havana, Cuba.

Preparation of inoculums, cell cultures, and technical handling of animals under bioethics and GLP regulations. Continuous technical support in laboratory analysis and drug product release.

EDUCATION

Doctor of Veterinary Medicine and Zootechnics | 2006, Agrarian University of Havana (UNAH)

Biological Processes Technician | 1996, Mártires de Girón Polytechnic Institute

SKILLS AND TECHNICAL COMPETENCIES

Regulations: GMP, GLP, Quality Assurance. Techniques: Cell Culture, Cell Bank Control, in vivo / in vitro Assays.

Management: International Audits, Leadership, Technical Reporting.

Processes: Inoculum Preparation, Biotechnological Scaling, Bioethics.