ABOUT TKD Solutions

Plug & Play CMC Experts

After decades of working in the CMC space, TKD Solutions founders Kirsten Pier and Dave Scuderi had an idea. What if they could form a company with the ability to literally plug into any organization and help them at any stage of their drug development path? Having familiarity with the common issues that companies struggled with on the CMC side, they knew they could come in and add instant value and expedite the path to approval, and get treatments to people who needed them. What started as a two person operation is now a diverse group of CMC experts that help biotech companies across the globe.

Passionate Problem Solvers

TKD Solutions consists of individuals with a unified vision. We get excited about the work. When there’s a problem, we combine our skills, experience, and specialized knowledge to find the right solution as efficiently as possible. Because we’re an agile company we can work together faster to get what you need without passing on overhead costs. We know that our success is a result of your success, so the TKD mindset is focused on providing cost effective solutions that save time, money, and get you closer to your goal.

TKD Solutions Guiding Values

Efficiency

For both our clients and the patients waiting for treatment time is everything. We do everything we can to help mitigate delays, and accelerate the path to approval.

Quality

Quality means taking the time to get it right the first time. From a safety, compliance and regulatory perspective we take pride in the work we do so you can avoid delays.

Flexibility

Flexibility means meeting you wherever you’re at in the path to approval and having the ability to jump in and add instant value.

Kirsten Pier

Principal Consultant
Owner

Kirsten is a CMC professional with over 18+ years experience from research through commercial phase process development & manufacturing. She has managed internal and external process development & manufacturing groups and successfully scaled out these groups appropriately through each phase of development. She considers herself a problem solver and enjoys working in a team environment.

When Kirsten is not working, she enjoys traveling, practicing & teaching yoga, and spending time outdoors hiking in Eastern Washington with her 3 rescue dogs and husband.

David Scuderi

Principal Consultant
Owner

Dave is a CMC professional with over 25 years experience in process development, cGMP clinical and cGMP commercial manufacturing. He comes with a proven ability to lead, hire, train, develop and retain highly talented staff. Dave has extensive experience leading cross functional CMC teams accountable for program strategy, continuity of clinical & commercial product supply, product lifecycle initiatives, regulatory filings enabling new market entries and support of post marketing commitments.

In his spare time Dave enjoys woodworking, traveling, and spending time hiking, backpacking, and exploring the wilderness with his wife and 3 dogs.

Lindsey Ingram

Senior Consultant

Lindsey has over 10 years of experience in biotechnology & process engineering including GMP manufacturing, facility upgrades/startup, and both upstream & downstream process development. She has supported programs from early development through clinical supply and commercial manufacturing including equipment & process validation activities, technology transfers, audits, and support of regulatory filings. She has managed development and manufacturing activities with external partners as well.

Lindsey loves being outside in the sunshine running, exploring a new place, or camping with her family.

Dana Paris

Senior Consultant, Supply Chain

Dana specializes in Supply Chain strategy development and implementation, as well as Project Management expertise with a diverse and lengthy background in the pharmaceutical industry; including oral solid dosage, dry powder inhaled, and cell and gene therapy products. She has a proven track record of effectively managing CMOs, shipping and transportation vendors, Clinical Trial Material distribution, Project Management of Technology Transfer, New Product Launches and cross functional collaboration across matrix teams.

In her free time, Dana enjoys running and watching her 2 boys’ soccer games.

Caroline Smith-Moore

Senior Consultant,
Analytical Development / QC

Caroline has a background in molecular biology, biochemistry, and specializes in analytical development and QC. She has a breadth of experience overseeing analytical development and QC activities at contract labs and CDMOs, as well as experience managing a contract academic lab. She is well versed in analytical method development, validation, and transfer. She has experience in cell and gene therapies, as well as biologics, and is adept at applying a variety of analytical tools and techniques to solve challenging problems. She is also an experienced trainer and educator in biomanufacturing.

In her spare time, she enjoys travel, tending her numerous plants, and visiting her family and friends.

Rebecca Kitchener

Senior Consultant, Analytical Development / QC

Becky has 18+ years of assay development experience in academic, clinical, research, and manufacturing settings. Her areas of expertise include analytical support of development activities surrounding biologics, vaccines, and gene therapies; as well as clinical genetic testing, and laboratory design/site start-up. She excels at assay optimization and troubleshooting; and is passionate about continuous improvement and generating meaningful data.

Outside of work, Becky enjoys gardening, bootcamp-style workouts, traveling, or just hanging at home in North Carolina with her husband, son, and three incorrigible rescue mutts.

Thomas Pack

Senior Consultant, Non Clinical
& Early Development

Tom is an early development professional with experience in discovery stage through clinical stage drug development in both small and large molecules. He has managed internal laboratory activities including assay development, device testing, cell line development as well as GLP small and large animal studies at CROs. He has also served as a clinical pharmacologist focusing on clinical delivery and bioanalytical assays. He likes to develop studies that are rooted in a drug’s mechanism of action and can lead to early demonstration of proof of concept. He has a PhD in Pharmacology from Duke University with a focus in receptor pharmacology, molecular biology, and neurobiology.

When Tom is not working, he enjoys fishing, reading science fiction novels, building things out of wood, and spending time outdoors hiking in North Carolina with his 2 daughters and wife.

Peter Jeff Nicholls

Senior Consultant, Research and Development

After serving as a Peace Corps volunteer in Namibia, PJ earned an MD at Columbia and headed to Duke to complete a residency in Psychiatry. From 2006 to 2022 he did basic neuroscience research full-time at Duke. In 2022 he began neuroscience research in industry.

In his free time, PJ does volunteer photography and bouldering.

Ready to Find the solution to get your product to the people who need it most?

Focus on what you do best and we’ll do the rest.