Meet Our Team
Founder
Meet Rebecca Lopez:
Rebecca Lopez is a highly accomplished leader with over 30 years of experience in the life sciences industry, specializing in guiding startup companies through the journey to commercialization. Her extensive expertise spans in facility build-outs, team scaling and management, quality assurance (QA), technology transfer, recruiting, aseptic techniques, ISO 5 gowning, and cleanroom cleaning and disinfection training. Rebecca has built her career in driving innovation, fostering operational excellence, and delivering results.
As a Director of Manufacturing, Rebecca has demonstrated exceptional skill in overseeing end-to-end production operations, implementing robust quality systems, and ensuring compliance with regulatory standards. She excels at optimizing manufacturing processes to enhance efficiency, reduce costs, and meet product launch timelines. Her hands-on approach to developing and mentoring teams creates high-performing environments that drive both individual and organizational success.
Rebecca’s ability to lead cross-functional teams, establish scalable processes, and navigate the complexities of the life sciences landscape makes her a trusted partner for organizations at all stages of growth. Her strategic leadership in facility design and build-out, coupled with her expertise in tech transfer, ensures seamless transitions from development to commercial production.
Fueled by her passion for advancing groundbreaking therapies, Rebecca is committed to supporting organizations that focus on finding cures for cancer and autoimmune diseases. Her dedication to making a meaningful impact is evident in her ability to develop strategies and solutions that help companies achieve their goals while delivering life-changing therapies to patients.
Rebecca’s unwavering commitment to excellence, her wealth of industry experience, and her collaborative leadership style make her an invaluable asset to any organization striving to bring innovative therapies to market.
Founding Partner
Meet Shena Weeks
Meet Elisa Carbonell
Elisa Carbonell brings over 25 years of Quality and Validation experience in the biopharmaceutical and biotech industries. Her validation expertise includes the development and execution of IQ, OQ, and PQ protocols for manufacturing equipment, cold rooms, laboratory equipment, critical utilities, CIP systems, and autoclaves.
As a detail-oriented and results-driven Validation Engineer, Elisa focuses on Quality Systems, including validation, implementation, troubleshooting, and support, ensuring compliance with applicable regulatory requirements. She consistently takes on roles as Project Manager or Project Lead, delivering exceptional service, maintaining project timelines, and achieving milestones with a "Quality First" mentality.
Automation & Computer System Validation
Elisa has extensive experience qualifying HMI/PLC-controlled equipment, including parts washers, autoclaves, filter integrity testers, rinsers, tunnels, and fillers. Her qualifications include alarms and interlock testing, screen verification, boundary testing, security, audit trails, sequence of operation testing, and trending.
She is also highly skilled in Computer System Validation (CSV) and Software Development Life Cycle (SDLC) activities in compliance with 21 CFR Part 11. Her CSV expertise includes data migration, implementing, validating, and supporting software applications for new or upgraded systems. This work encompasses all aspects of documentation, from business and user requirements to risk assessments, test script development/execution, validation summary reports, and entry into service reports.
About Us
Our Life Sciences consulting business provides comprehensive solutions tailored to support companies in the biopharmaceutical, pharmaceutical, and medical device industries. We specialize in Engineering, Validation, Commissioning, Quality, and Regulatory services, ensuring your operations meet the highest industry standards.
Our expertise spans across Operations, Documentation, New Construction, ISO compliance, Program and Project Management, and Business Process Management. From facility and equipment validation to commissioning, we deliver seamless solutions to optimize manufacturing processes and ensure regulatory compliance.
With a focus on innovation and efficiency, we partner with clients to streamline operations and accelerate success in today’s competitive life sciences landscape.
Our Mission
At Gene Bio Partners, a proud woman-owned business, our mission is to empower pharmaceuticals, biologics, and cell and gene therapy companies by providing innovative and strategic consulting solutions. We are dedicated to advancing development programs, ensuring operational readiness, and achieving regulatory compliance from clinical trials to commercialization and beyond. Through our expertise and commitment, we strive to drive innovation, foster sustainability, and help our clients deliver life-changing therapies to patients worldwide.
