Your Team,
Extended.

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

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

Dave is a CMC professional with 25+ years of experience in process development, CGMP clinical, and CGMP commercial manufacturing. Dave has a proven ability to train, develop, retain, and lead highly talented staff. He has extensive experience leading cross-functional CMC teams that are accountable for program strategies, continuities of clinical and commercial product supplies, product lifecycle initiatives, regulatory filings enabling new market entries, and support of post marketing commitments.

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

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

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

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

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

Becky has 18+ years of experience of assay development in academic, clinical, research, and manufacturing settings. Her areas of expertise include analytical support of development activities surrounding biologics, vaccines, and gene therapies, such as clinical genetic testing. She also has experience with laboratory design and site startup. 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 3 incorrigible rescue mutts.

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, such as assay development, device testing, and cell line development, as well as GLP small and large animal studies at CROs. His previous experience as a clinical pharmacologist focusing on clinical delivery and bioanalytical assays led to his passion for developing studies 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.

PJ has 16+ years of experience in basic neuroscience research at Duke. Before completing his MD at Columbia and his Psychiatry residency at Duke, PJ served as a Peace Corps volunteer in Namibia. In 2022, he began neuroscience research in industry.

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

Aigee has 10+ years of experience in process engineering, specializing in pilot and GMP manufacturing for both drug substances and drug products. She has been instrumental in various aspects of the industry, from facility startup to technology transfers, encompassing equipment and process validation, vendor management, quality audits, and adept navigation of regulatory filings. Her contributions span from supporting programs in their early phase all throughout commercial. Aigee is an enthusiastic problem solver, viewing each challenge as an opportunity for growth and learning.

In her spare time, Aigee enjoys practicing Brazilian jiujitsu and spending time with her family.