Jennifer Riter, Vice President of Analytical and Development Services at Kindeva, is a seasoned pharmaceutical leader with deep expertise in analytical testing, extractable and leachable (E&L), and combination product development. From building contract labs from the ground up to advancing integrated drug-device strategies, she leads with a focus on scientific rigor, regulatory insight, and cross-functional innovation. With a career spanning technical bench work and executive leadership, Riter champions high-quality science that accelerates development while safeguarding patient safety.
In an exclusive interview with Pharma Tech Outlook, she shared her invaluable thoughts on redefining pharmaceutical analytical services. She emphasizes the importance of cross-functional expertise, regulatory foresight, and patient-centered innovation in today’s rapidly evolving therapeutic landscape.
Strategic Growth through Hands-On Insight
Throughout my career, I have been fortunate to lead analytical and development services in some of the most dynamic areas of the pharmaceutical industry. One of the most formative chapters began during my time at West Pharmaceutical Services. I wore many hats, starting in technical bench roles, supporting customers directly, and eventually leading the development of West’s contract analytical services function. In 1999, we established a dedicated laboratory within the company to provide analytical services for container closure and device testing. Contributing to the lab’s development, from helping establish its foundation to shaping the service offering and positioning West as a trusted partner in the pharmaceutical and biotech industries, was a pivotal experience.
That early exposure to the strategic and technical facets of lab operations provided me with a deep insight into what it takes to build something sustainable and customer-centric from the ground up. I gained experience as a chemist and learned how to read industry needs and translate them into viable service solutions. That foundation proved invaluable when I joined Kindeva. They were looking for someone to launch and lead an independent analytical services business unit, and I was able to bring the strategic vision and hands-on know-how to get it off the ground successfully.
Designing with Purpose, Delivering with Impact
I lead a team that supports analytical development across a wide range of modalities and delivery systems, from traditional vial-stopper-seal containment to complex combination products, such as auto-injectors, nasal sprays, and inhalation devices. Our approach at Kindeva starts by viewing a product holistically. Drug formulation is only one piece of the puzzle; containment, delivery, safety, and regulatory compliance are equally critical.
The goal is always the same, to accelerate development while ensuring the safety, quality, and effectiveness of the product for patients.
We work closely with our clients from day one to map out a comprehensive analytical roadmap. That involves understanding the clinical and regulatory objectives early on and helping define the tests and validations required to meet those goals. Whether it is a traditional injectable or a next-generation therapy delivered through an integrated device, we build our strategy around the product lifecycle, from early development through to commercialization. We also remain agile, continually adapting our approach as regulatory expectations evolve or as scientific advancements progress.
The goal is always the same: to accelerate development while ensuring the safety, quality, and effectiveness of the product for patients.
Maintaining Consistency and Quality across Diverse Services
Our laboratory offers a comprehensive range of analytical services, including method development, validation, stability testing, and extractable and leachable (E&L) analysis. These areas are all highly specialized, so ensuring consistency and quality means bringing in the right talent with the right expertise.
E&L, for instance, requires a deep understanding of materials science and container-closure interactions, whereas method development for a drug product leans more heavily on analytical chemistry. On the other hand, physical and functional testing, such as mechanical validation for combination devices, requires engineering expertise and a different methodological approach.
We do not just test. We solve problems. That means our team needs to understand how to run a test, interpret results, anticipate issues, and resolve unexpected challenges. We hire with that mindset. Our structure ensures that each service line is led by individuals with specific domain expertise, whether in chemical analysis, mechanical testing, or regulatory affairs, allowing us to maintain rigor and quality across all service types.
The processes, SOPs, and quality oversight must be sound, but it is the skillset and analytical judgment of our team that ensures each result we deliver is reliable and actionable.
Responding to Evolving Rules and Therapies
One of today’s biggest challenges is keeping pace with evolving regulatory expectations, especially for combination products. Traditionally, drugs were developed first, with delivery methods considered later. Now, drug and device development must happen in parallel from the outset. This integrated approach demands that developers also understand mechanical design, device performance, and human factors.
Further complicating matters are complex biologics, cell, and gene therapies, which often require specialized handling, containment, and supply chain management. It’s not just about the drug’s efficacy—it’s also about ensuring the delivery system is equally reliable and compliant.
Staying ahead means continually tracking guidance updates, building flexibility into analytical plans, and fostering strong client partnerships. We act as an extension of our clients’ teams, embedding regulatory compliance into development from the start. This is especially critical for smaller biotechs that may lack in-house expertise. We’re more than a testing lab—we’re a trusted partner from development through commercialization.
Empowering Leadership Through Mindset
Stepping into leadership in pharmaceutical analytics requires creative thinking grounded in compliance. Innovation often demands looking beyond traditional boundaries, but quality and regulatory integrity must remain intact. For instance, we’ve adapted mechanical testing methods from automotive and aerospace industries to validate pharmaceutical devices. These fields offer valuable engineering standards, but methods must be tailored to meet pharmaceutical regulations and properly validated.
Future leaders should seek cross-industry inspiration while developing deep respect for our regulatory environment. True innovation arises from being open, flexible, and curious—without compromising compliance.
Leadership in this space goes beyond technical skill. It involves building systems, developing talent, guiding clients through complexity, and staying prepared for what’s next. Whether it’s interpreting data, mapping a development strategy, or integrating new testing approaches, our role is more than service—it’s strategic partnership.
As the industry evolves, so do we. With the right mindset, expertise, and commitment to quality, we help deliver innovative, effective therapies to patients worldwide.
