CMC project manager with 20 years of experience in the biopharmaceutical industry, from research & development to clinical phase and commercial manufacturing, including tech transfers of immunodiagnostic, personalized cancer immunotherapy, and C> products.
Heather is a proven leader in CMC project/program management, specializing in technology transfers, new product introductions and CMO/CDMO management. Her experience covers a broad array of products including tumor specific cancer immunotherapeutics and cell & gene therapies. Heather has spent much of her career managing joint business and CMO partnerships and brings expertise in leading cross-functional teams, project review boards and joint steering committees.
After earning her MS in Pharmacology and Toxicology, Heather began her professional career in R&D at Chiron and Novartis developing next generation clinical diagnostic immunoassays for HIV and Hepatitis before transitioning into project management to support the technical operations and cross-functional CMC teams at Novartis Diagnostics.
After 15 years at Chiron/Novartis/Grifols, Heather joined Sangamo Therapeutics where she managed CMO activities and deliverables in support of multiple clinical programs and IND submissions for adeno-associated virus (AAV) vector products. While leading CMC project management at Sangamo, Heather wrote and managed request for proposals (RFPs), master service agreements (MSAs) and statements of work (SOWs) and provided hands-on leadership for supply chain and clinical kit packaging.
While at Dynavax Technologies Heather supported clinical manufacturing, QA, QC, regulatory, and analytical development teams both internally and externally. Heather managed CMC timelines and led project kick-offs and the project review board.
Heather joined Orchard Therapeutics in 2017 where she led CMC project management and CMO project & alliance management. As the sole CMC project manager early on, Heather led internal and external tech transfer and project team activities in support of IND and BLA submissions for lentiviral vectors and autologous cell therapy drug products. Heather later built the CMC project management team at Orchard and supported implementation of project management best practices.
Prior to joining Dark Horse, Heather built the CMC project management function at Gritstone Oncology. At Gritstone, Heather established project management best practices and was integral in developing site process development and manufacturing strategies related to plasmids, viral vectors and RNA lipidnanoparticles. Heather was instrumental in building the framework for successful tech transfers into Gritstone’s GMP clinical manufacturing facility by authoring tech transfer and comparability protocols and reports and leading cross-functional teams.
EXAMPLES OF RECENT WORK
- Supported introduction of new products into clinical manufacturing.
- Alliance management and strategic planning.
- Led multiple successful technology transfers from CMOs, process development and R&D to internal GMP manufacturing site as well as transfer of processes to commercial CMOs.
- Managed CMC development plans and CMC sections of integrated development plans (IDPs)
Research Associate, R&D