PDA Puerto Rico
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OUR CHAPTER
The Puerto Rico Chapter is committed to advancing pharmaceutical and biopharmaceutical excellence across the island by connecting people, science, regulation, and leadership. As part of PDA’s global network, the chapter provides a platform for professionals in industry, academia, and regulatory agencies to collaborate, exchange knowledge, and strengthen the region’s role in serving patients globally.
Vision
To maximize product quality, availability, and value by connecting people, science, and regulation within the pharmaceutical and biopharmaceutical community.
Mission
To advance pharmaceutical manufacturing science and regulation so members can better serve patients.
Focus Areas
- People: Grow membership, expand networking opportunities, and establish a student chapter to prepare the next generation of professionals.
- Science: Share emerging manufacturing trends, including AI applications, facilitate knowledge exchange, and address local talent gaps.
- Regulation: Educate members on evolving regulatory expectations, integrate science and technology with regulatory requirements, and be a leading voice in guidance implementation.
- Leadership: Promote mentorship, define essential leadership skills, and build strategic partnerships to achieve chapter goals.
Through these initiatives, the PDA Puerto Rico Chapter supports professional growth, fosters innovation, and strengthens Puerto Rico’s position in leading pharmaceutical and biopharmaceutical development.
Members at Large:
- Mirian Alvarez, Director, Pharmalex
- Neftali Feliciano, QA Director, Amgen
- Franceska Hamilton, Associate Director, Analytical Lab, Bristol Myers Squibb
- Silvette Mirand, Associate Director, Manufacturing (Parenteral), AbbVie
- Sandra Molina, Director, Pharma-Bio Serv
- Armando Morales, Director, Pharma-Bio Serv
- Jenisse Neris Molina, MSAT LM DP Site Sr. Manager, J&J Innovative Medicines
- Cynthia E. Romero, Medical Scientist Liaison, GlaxoSmithKline
- Daniel Sanchez, Consultant, Gintegra
- Victor Sanchez, CEO, Pharma-Bio Serv
- Bethsymarie Soto, Account Manager, Millipore Sigma
Chapter Officers
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Myrta AtilesExecutive Director, Global Operations Commercialization
President
Amgen
Myrta Atiles has been with Amgen since 2003 and is currently Executive Director of Oncology Global Operations Commercialization. Previously, she managed as Plant Manager, Amgen Juncos’ largest Parenteral Drug Product facility and led Process Development for oral dosage forms and packaging. She was the Amgen lead in collaborating with Eli Lilly to manufacture Covid-19 antibody treatments and has shared her expertise as a panelist at ACC Bio and ISPE conferences.
During her tenure at Amgen, she has held a variety of roles with increasing responsibility, including Global Operations Lead for oncology programs and Senior Scientist for Drug Substance at Amgen Juncos. Myrta has successfully led more than 50 Technology Transfer programs ranging from Drug Substance to Drug Product, which includes over 20 new product launches, facility start-ups, and the introduction of new technology. She pioneered platform standardization for filling technology within the Amgen network and spearheaded the implementation of Artificial Intelligence for automated inspection processes.
Myrta exemplifies leadership that goes far beyond her core job responsibilities. By taking on the role of president for Amgen’s women’s diversity group, she championed inclusivity and inspired colleagues through purposeful initiatives. Her stewardship of the DP plant manager network fostered collaboration and knowledge sharing across teams. In 2024, as president of the PDA PR chapter, Myrta strategically revitalized the organization—boosting membership by over 50% within a year—demonstrating her commitment to growth, empowerment, and shaping organizational culture outside her formal position.
Before joining Amgen in 2003, Myrta held a series of Research and Development Scientist roles at Cellular Genomics (CT) and Third Wave Technologies (WI). At Third Wave Technologies, in addition to her responsibilities as a research scientist, she collaborated with the marketing team on the company's Road Show Strategy across multiple countries.
Myrta holds a bachelor's degree in industrial microbiology from the University of Puerto Rico, Mayagüez, and a master's degree in Bacteriology and Molecular Biology from the University of Wisconsin, Madison.
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Omar CruzSr. Global Technical Services Specialist
President-Elect
Contec
Omar Cruz is an Industrial Microbiologist with more than 30 years of experience in the pharmaceutical and biotechnology industry, specializing in contamination control, aseptic processing, and microbiological method validations. Currently serving as Sr. Global Technical Services Specialist at Contec Inc., he provides expertise in contamination control assessments, disinfectant efficacy testing, and Annex 1–aligned contamination control strategies across LATAM and the U.S.
For more than 18 years at Bristol Myers Squibb and Johnson & Johnson (J&J), Omar held senior leadership positions where he drove operational excellence and innovation in microbiology and contamination control. He led major initiatives to enhance training, modernize microbial identification with technologies such as MALDI-TOF and MicroSeq DNA sequencing, and redesign environmental monitoring programs. His leadership delivered measurable improvements in regulatory compliance, organizational efficiency, and cost optimization across multiple manufacturing platforms, including Fill & Finish, Bulk, OSD, and medical devices.
Omar has been an active contributor to industry standards and guidance. He serves on the PDA Technical Report #3 and #70 revision task forces and co-authored IEST technical publications on environmental monitoring. His leadership extends beyond the laboratory: as President-Elect and Board Member of the PDA Puerto Rico Chapter, he supports the coordination of high-profile industry events in Puerto Rico. Also, it coordinates technical events at LATAM, including technical web seminars with an international audience.
Throughout his career, Omar has been recognized as a subject matter expert on disinfectant validation programs, sterility testing, environmental monitoring, and contamination-control programs. He has supported regulatory remediation efforts, designed enterprise-wide sterility policies, and mentored teams across multiple global manufacturing sites. His blend of technical expertise, regulatory insight, and commitment to knowledge-sharing continues to influence best practices in pharmaceutical microbiology and contamination control.
Omar holds a B.S. in Industrial Microbiology and Biology from the University of Puerto Rico, Mayagüez, with additional graduate academic education in Food Science and Technology
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Andrea GiraldoAccount Manager & Consultant
Secretary
Steris
Andrea Giraldo is an Account Manager and Consultant at STERIS with over a decade of progressive experience in the pharmaceutical industry. She has partnered with leading organizations in biotechnology, medical devices, and oral solid dosage (OSD) manufacturing to provide technical expertise, strategic guidance, and innovative solutions tailored to complex operational challenges.
With a background in Industrial Engineering, Andrea has built her career on driving process improvements, strengthening compliance with stringent regulatory requirements, and optimizing critical operations such as cleaning, disinfection, and sterilization. Her expertise includes supporting large-scale manufacturing facilities, collaborating with cross-functional teams, and implementing best practices that enhance productivity, reduce costs, and improve quality outcomes.
Andrea is committed to helping organizations achieve operational excellence while upholding the highest standards of safety and compliance. In every engagement, she focuses on understanding each organization’s unique needs and aligning solutions that ensure efficiency, reliability, and regulatory readiness. As a trusted partner, she combines technical acumen with strategic insight to deliver lasting value across diverse pharmaceutical environments.
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Walquiria PolancoConsultant
Treasurer
Walquiria Polanco-Gracia is an accomplished executive with over 20 years of experience in the pharmaceutical and biotech industry. She holds a Bachelor’s degree in Mechanical Engineering from the University of Puerto Rico–Mayagüez and has completed executive education programs at the Kellogg School of Management.
Throughout her career, she has led sales strategies, strengthened client relationships, and delivered high-impact consulting in FDA GMP, validation, quality systems, and product transfer. She has also played a key role in the technical transfer of sterile products and the qualification of multiple fill-and-finish facilities, with expertise in sterilization, aseptic simulations, and drug product manufacturing.
Her core strengths span sales leadership, business development, and technical consulting, always anchored in collaboration, innovation, and a commitment to excellence in a fast-evolving industry.
Chapter Resources
Discover essential materials such as the chapter handbook, templates, presentations, and insightful videos tailored for new chapter leaders and the GPS network.
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