A leadership and industry development, Dr. Bettine Boltres is teaching upcoming scientists and is an author for a winning publication on pharmaceutical glass. With a lifetime passion for health that has carried her from the lab bench to leadership that drove global pharmaceutical packaging regulation, she knows many times more than material science.
In her present role as Director of Scientific Affairs, Integrated Systems at West Pharmaceutical Services, she is shaping the next generation of professionals and driving packaging solution innovation. Her commitment to the convergence of research and practice is clearly seen in her life as writer, teacher, and business leader. Her mentorship guarantees that her legacy will be transmitted by empowering new voices and shaping their future.
From Lab Bench to Global Impact
Dr. Boltres’ path to pharmaceutical packaging leadership began with a fundamental passion for healthcare. “I have always been interested in everything around health care.” she reflects, describing how this intrinsic motivation guided her career choices from the very beginning.
After completing her doctorate in biochemistry, she joined Schott’s pharmaceutical business unit through their graduate program, a decision that later proved transformative. The comprehensive 1.5-year program took her through manufacturing plants across Germany, Switzerland, and the United States, providing her with an invaluable foundation in both glass materials science and global pharmaceutical operations.
“This experience was incredibly instructive. I am deeply thankful for this experience as it enriched my understanding of glass and the pharmaceutical sector.” Dr. Boltres recalls. During her seven years at Schott, she didn’t just learn she taught, becoming a sought-after lecturer worldwide and contributing to the FIOLAX Academy, Schott’s external education program.
It was during this period that she witnessed a pivotal industry transformation. “Pharmaceutical companies showed increasing interest in learning about the materials they are using based on more detailed inquiries from regulatory agencies.” she explains. This shift from random component selection to science-driven material understanding inspired her to author a comprehensive book on glass applications in pharmaceuticals bridging the gap between overly technical glass literature and the brief packaging sections found in drug development texts.
The West Pharmaceutical Services Chapter
After seven enriching years at Schott, Dr. Boltres felt ready to embrace new challenges, leading her to West Pharmaceutical Services. The transition allowed her to expand her expertise beyond glass materials, combining her deep glass knowledge with elastomer science to develop a more comprehensive understanding of pharmaceutical packaging systems.
“Moving to West, I further enhanced my understanding of the big picture and how all individual parts are synchronized within this big picture.” she explains. This holistic perspective would become central to her approach to packaging science and her role in advancing industry standards.
In her current role as Director of Scientific Affairs, she is serving as a crucial bridge between West’s innovative packaging solutions and the pharmaceutical industry’s evolving needs. Her work goes far beyond traditional supplier relationships, focusing instead on fostering genuine scientific collaboration that advances the entire industry.
Championing Collaborative Innovation
Central to Dr. Boltres’ philosophy is the belief that meaningful progress requires industry-wide collaboration. “I have always been convinced that the only way to move the industry forward is through collaboration,” she states emphatically. This conviction led her to join the PDA in 2011, where she has become increasingly involved in shaping industry standards and practices.
Her contributions to PDA span multiple roles: from early involvement in the planning committee for the European Parenteral Packaging conference to serving as Interest Group Lead, Task Force member writing Technical Reports, and providing training and presentations. In 2019, she joined the Board of Directors of PDA, further cementing her influence on industry direction.
“PDA is the ideal platform to facilitate exchange as they bring the entire industry together: component suppliers, pharmaceutical companies, machine vendors, regulators, consultants, and so on. You cannot evolve by yourself in your little chamber. You have to go out and see what the world is doing.” she explains.
Her collaborative approach extends beyond formal industry associations. She is actively using her broad network throughout the industry to connect people and topics, fostering the kind of cross-pollination of ideas that drives innovation forward.
Addressing Industry Challenges Through Innovation
One of the most significant challenges Dr. Boltres has encountered is facilitating knowledge exchange while respecting competitive boundaries. “You need to build some trust to exchange knowledge. You have to find a way to bring people together to discuss challenges and provide their insights without giving away confidential information.” she explains.
This challenge is particularly acute when pharmaceutical companies work with multiple suppliers for the development of their container closure systems or combination products. The result is often “tedious 3-way CDAs, disaggregated information and misaligned coordination,” she notes. Smaller companies often “do not know what they do not know,” while larger multinational companies can become “chaotic within” due to their size and complexity.
These challenges had a direct influence on West’s development of the West Synchrony™ Prefillable Syringe (PFS) System, a fully verified integrated solution that addresses many of these pain points. “It is a fully integrated and verified prefillable syringe system, it removes a lot of the complexity, insecurity and time-consuming efforts currently existing in the industry.” Dr. Boltres explains.
This innovation is representing a paradigm shift from component-driven approaches to system-based solutions, allowing pharmaceutical companies to skip complex multi-supplier coordination and move directly into drug dependent design verification testing.
Quality by Design: Speaking the Industry’s Language
Dr. Boltres’ approach to developing high-value packaging solutions is deeply rooted in Quality by Design (QbD) principles. “If you want to develop something that is of value for the pharmaceutical industry, then you have to speak their language and think their way.” she explains.
QbD’s systematic approach beginning with predefined objectives and emphasizing product and process understanding based on sound science and quality risk management has been central to West’s development philosophy. This approach was instrumental in creating the NovaPure® elastomer components portfolio and continues to guide the company’s innovation strategy.
Looking ahead, Dr. Boltres is seeing an even greater need for this systematic approach as the industry grapples with the emergence of combination products and the convergence of pharmaceutical and medical device regulatory frameworks. “We are not just component suppliers anymore; we manufacture the device part of the combination product. This rethinking is going to shape the development, manufacturing and regulatory landscape on a global level over the next decades.” she notes.
Shaping Industry Standards and Harmonization
Dr. Boltres’ influence extends well beyond West Pharmaceutical Services through her leadership roles in multiple industry organizations. As a member of the PDA Board of Directors, the USP Packaging & Distribution Expert Committee, European Pharmacopeia Working Groups, and ISO Technical Committee 76, she consistently striving to align and harmonize the industry to avoid time consuming redundancies.
Her contributions to industry guidance documents are particularly noteworthy. PDA Technical Reports such as TR-87 on glass handling have become essential references for the entire industry. When Notified Bodies became more heavily involved in assessing prefillable syringe safety and performance, creating uncertainty about submission requirements, she helped developing TR 73-2 on MDR GSPRs for PFS, including comprehensive guidance on documentation requirements.
“I am very confident that this report can save companies a lot of time and nerves.” she reflects, demonstrating her practical focus on solving real-world industry challenges.
Leadership Philosophy and Mentorship
For Dr. Boltres, leadership goes far beyond title or position. “Leadership means having a vision and inspiring people with it. This naturally comes along with persistence and especially in our pharma world which is turning very slowly.” she explains.
Her leadership philosophy acknowledges that meaningful change often requires difficult conversations and sustained effort. “Sometimes you need to go on the hard road and fight for your vision. People are not always ready for big new changes.” she notes, citing sustainability initiatives as an example of necessary but challenging industry transformation.
Mentorship plays a crucial role in her leadership approach. “Everything you build is going to collapse once you are gone if you don’t have anyone continuing it.” she emphasizes. When she identifies individuals eager to grow, she is actively promoting them into positions where they can develop their potential.
Her mentorship philosophy focuses on developing independent thinking rather than mere compliance. According to her what is important for them to learn is not just to do things because they were told to do so, but because they think it is the right thing to do. That way they can develop their own vision and start working towards that.
Vision for the Future
Dr. Boltres sees two major trends shaping pharmaceutical packaging’s future. The first involves the precision medicine revolution enabled by advances in genomics and proteomics, supported by artificial intelligence. “We are going to be able to tailor treatments more to the patient and find out early on if they are responders or not.” she explains, noting that this approach will expand far beyond current applications like BRCA gene testing for breast cancer treatment.
The second trend involves a fundamental shift from reactive to proactive healthcare. “With a deeper understanding of the interactions between existing single nucleotid polymorphisms (SNPs) and learned lifestyle, we will be able to move from a reactive to a more proactive preventative way of dealing with our health and diseases.”
Sustainability as a Personal Mission
Perhaps most passionate among Dr. Boltres’ future-focused initiatives is her deep commitment to sustainability. “From a personal lens, I am most excited about the move towards a more sustainable way of living on this planet,” she states with conviction. For her, this journey is not an abstract ideal but a necessary shift in how humanity understands its relationship with the world. “People need to realize that sustainability isn’t just about saving a planet it’s about preserving our own lives and those of future generations, since everything we do ultimately comes back to us,” she emphasizes.
She firmly believes that the healthcare industry can achieve ambitious sustainability goals without compromising patient safety. “I know that we as a healthcare industry are going to be able to combine a sustainable way of developing, manufacturing and recycling our healthcare products with continuing to put patient safety first. This is by no means a contradiction.”
This conviction fuels much of her advocacy across industry organizations, where she consistently champions sustainable practices, forward-thinking innovation, and a collective responsibility to build a healthier future. for both people and the planet.
This vision drives much of her advocacy work across industry organizations, where she consistently promotes sustainable practices and thinking.
A Legacy of Scientific Excellence
Dr. Bettine Boltres represents the best of what pharmaceutical packaging science can achieve: rigorous scientific thinking combined with collaborative leadership and a clear vision for industry advancement. Her career demonstrates that meaningful progress comes not from working in isolation, but from building bridges between organizations, disciplines, and ways of thinking.
As the pharmaceutical industry continues to evolve, with new therapeutic modalities, changing regulatory landscapes, and growing sustainability imperatives leaders like Dr. Boltres will be essential in navigating these challenges while maintaining the scientific rigor that ensures patient safety and therapeutic efficacy.
In an industry where the stakes couldn’t be higher where packaging failures can mean the difference between therapeutic success and patient harm her commitment to excellence, collaboration, and continuous improvement ensures that pharmaceutical packaging science will continue to advance in service of better patient outcomes worldwide.