Technical Team

GBI’s technical team consist of members with extensive experience in biologics and cGMP manufacturing. They all successfully manage their teams to create high quality and cGMP compliant product for over 150 satisfied clients.

Prema Rathinavelu, MSc Associate Vice President of Quality Control

Andrew Majdoch, MSc Associate Vice President of Technical Operations

Roger Wong, Ph.D., MBA Senior Director, Business Development (West Coast)

Joscar Guivas Senior Director of Manufacturing and Supply Chain

Catherine Uitz, Ph.D. Director of Process Development

Sandra Isaacs Director of Quality Assurance

Chris Benjamin IT Manager

Prema Rathinavelu, MSc Associate Vice President of Quality Control

With over 17 years of experience in managing quality assurance and quality control departments, Prema has leveraged a solid scientific background with technical experience in biochemistry, microbiology, and chemistry, working on all aspects of early-stage drug development including analytical method development and validation as well as establishing product specifications. She has a deep understanding of USP and EP methodologies, which enables her to provide guidance and oversight for the release and testing of API, finished products, and raw materials. Prema attended the University of Madras, where she earned a Master’s degree in biochemistry and an undergraduate degree in chemistry, and has published several research papers in reputable, peer-reviewed biological journals.

Andrew Majdoch, MSc Associate Vice President of Technical Operations

Andrew has over 20 years of experience in manufacturing biologics and biopharmaceuticals. Prior to joining GBI, Andrew was the Senior Manager – Clinical Manufacturing and Process Development at Alkermes plc, where he worked for 13 years in manufacturing (commercial and clinical) and process development.

Andrew has experience developing drug candidates in the large molecule design space focusing on recombinant therapeutic proteins. Andrew began his career with Abbott Laboratories where he worked for 7 years moving up through the ranks to become the Rare Reagents Manufacturing Supervisor overseeing the mAb production suite.

Andrew earned his Masters of Science degree in engineering and technology management from Oklahoma State University and a Bachelor of Science degree in biology from the University of Wisconsin.

Roger Wong, Ph.D., MBA Senior Director, Business Development (West Coast)

Roger carries expertise in both small molecule and biologics drug discovery and development for over 20 years, and his roles with increasing responsibilities include SVP and co-founder at Anven Biosciences, principal investigator and faculty at universities. Roger has been a client advocate and worked as business development executives in the CRO and CDMO including Eurofins and Abzena. Roger received his Ph.D. at UC Berkeley and MBA at Hough School of Business.

Joscar Guivas Senior Director of Manufacturing and Supply Chain

Joscar Guivas Fabery is our Senior Manufacturing and Supply Chain Director. Joscar is an strategic and results-driven leader with 10+ years of experience in biologics commercial manufacturing. As a Lean Six Sigma Black Belt and Hoshin Kanri Certified professional, Joscar has led and coached continuous improvement and strategic planning implementations and has a proven track record of executing supply chain and manufacturing process improvement projects.

At GBI, Joscar is responsible for all manufacturing operations including GMP and non-GMP upstream, downstream, and fill finish as well as associated support activities such as materials management and facilities.

Joscar started his career at Amgen Puerto Rico, where he supported commercial startup operations in the formulation and drug product facility. In addition to Amgen, Joscar worked at Mylan and Emergent BioSolutions to drive and improve commercial manufacturing.

Catherine Uitz, Ph.D. Director of Process Development

Catherine Uitz, PhD, was most recently the consultant of USAID Global Health Supply Chain Program-Procurement and Supply Management and was previously the Associate Director at Novavax, where she was accountable for process development and attribute characterization to defend the integrated control strategy of flu VLP. She has worked in US FDA and WHO approved drugs, Process Development, and Manufacturing Sciences on a variety of product types (ACTs, RDTs, LLINs, ARVs, NuThrax™, PreviThrax™, NicVax, NEISVAC-C® , novel semi-synthetic conjugate vaccines) and at small and large companies (Emergent, Nabi Biopharmaceuticals and Baxter Bioscience). Catherine possesses numerous patents, publications, and corporate technical team awards.

Catherine has a BSc and PhD in Organic Chemistry from University Paris XI – Institute Curie, Paris, France.

Sandra Isaacs Director of Quality Assurance

Sandra Isaacs is a Quality Professional with over two decades of experience in developing, monitoring, and spearheading continuous improvement measures to attain a sustainable and compliant Quality Management System framework. She has broad industry experience in the Biologics, Drugs, Medical Devices, Human Cells, Tissues and Cellular and Tissue -Based Products (HCT/P) industry.

She attended the University of South Florida where she obtained a post-graduate diploma in Total Quality Management. She also holds a Bachelor of Science degree with a major in Chemistry and minors in Physics and Biochemistry from the University of the West Indies. In 2004 she satisfactorily fulfilled the requirements established by ASQ and attained her professional certification as a Certified Quality Auditor (CQA).

Sandra joined the Goodwin Biotechnology Inc. (GBI) team in 2009. During her tenure, she works closely with global Quality partners to ensure that clinical phase therapeutic biologics manufactured by GBI meet the requisite national and international quality standards. She is adept to client’s needs and prides herself in establishing a working collaboration with the client’s quality representatives to build mutual trust and transparency.

Sandra is currently the Quality Director for manufacturing operations. In this capacity she oversees operational activities and works to establish strategic Quality Operational plans to support GBI’s commercialization activities. She is driving a ‘Quality First’ culture and is reinforcing the company’s Quality Organization based on quality risk management principles. It is her objective to continue to build and expand the company’s Quality Management System to ensure that it is designed optimally and compliant for a seamless transition to commercial manufacturing.

Chris Benjamin IT Manager

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