Open to opportunities

lisset casado

@lissetcasado

Message

Regulatory Affair. CMC. Specialist in Biotechnology with 10+ years' in process development expertise.

Cuba

Message

What I'm looking for

I am seeking roles where I can contribute experience in quality, regulation, and process development in the biopharmaceutical field, within collaborative and innovation-oriented teams.

I am a Quality Management specialist in the biotechnology sector with over ten years of experience in hybridoma cell culture and in developing fermentation and purification processes for the production of monoclonal antibodies.

I have led production and process optimization projects, including the implementation of disposable bioreactors and downstream processing steps (clarification, purification, concentration, and formulation) for diagnostic reagents and biopharmaceutical products.

As a Regulatory Affairs Specialist, I am responsible for preparing documentation for national and international regulatory agencies, and I have participated in obtaining product registration approvals and clinical trial authorizations for COVID-19 vaccines and related products in several countries.

My strengths include problem-solving, teamwork, leadership, and my technical expertise in spectrophotometry, chromatography, electrophoresis, and biopharmaceutical analysis. This is complemented by a Master's degree in Biotechnology and a postgraduate diploma in Quality Assurance and Control.

Experience

Work history, roles, and key accomplishments

Current

Specialist, Regulatory Affairs

Current

Centro de Inmunología Molecular

Jan 2019 - Present (6 years 8 months)

Prepared regulatory documentation for clinical trial applications and product registrations, securing approvals for vaccines and COVID-related products in multiple countries including Cuba, Mexico and Iran. Managed regulatory submissions covering development, control testing and manufacturing for biopharmaceuticals.

Regulatory Quality Management Biopharmaceutical Technical Writing

Principal Fermentation Specialist

Centro de Inmunología Molecular

Jan 2017 - Dec 2018 (1 year 11 months)

Led fermentation group activities, supervising inoculum and culture supernatant production and establishing new hybridoma cell culture processes for hemoclassifier development. Managed project delivery for ABO hemoclassifier development and process establishment.

Cell Culture Hybridoma Technology Project Management Inoculum Preparation Process Optimization SOPs

Fermentation Specialist

Centro de Inmunología Molecular

Oct 2014 - Dec 2016 (2 years 2 months)

Implemented disposable wave bioreactor technology and downstream processes (clarification, purification, concentration, formulation, filling) for in vitro production of leukocyte monoclonal antibodies and diagnostic reagents. Developed cell cultures for ABO blood typing reagents.

Wave Bioreactors Downstream Processing Affinity Chromatography Concentration Formulation

Training Technician

Centro de Inmunología Molecular

Sep 2011 - Sep 2014 (3 years)

Prepared culture media and purification solutions, performed hybridoma cell culture in T-flasks and hollow-fiber fermenters, and operated 50L Applikon wave bioreactors; executed antibody purification by ion exchange, affinity and gel filtration.

Media Preparation Hybridoma Culture Hollow Fiber Fermentation Wave Bioreactor Operation Ion Exchange Affinity Chromatography Gel Filtration

Education

Degrees, certifications, and relevant coursework

University of Havana

Postgraduate Diploma, Quality Assurance & Control of Pharmaceutical and Biotechnological Product and Process

2023 - 2024

Activities and societies: Quality Assurance & Control (GMP, QC, QA)

University of Oriente

Master of Science, Industrial Biotechnology

2015 - 2017

Grade: 4.83 / 5.00

Activities and societies: Process Development | Fermentation & Downstream Processing | Analytical Techniques

University of Oriente

Bachelor of Engineering, Chemical Engineering

2006 - 2011

Grade: 4.93/ 5.00

Activities and societies: Tutorización de tesis de diploma de 3 estudiantes de pregrado

I graduated with a degree in Chemical Engineering, achieving a GPA of 4.93 out of 5.00. I received the Gold Medal award for academic excellence and was also recognized as the Best Teaching Student.