CMC project manager with experience from R&D to clinical phase and commercial stages, including tech transfers
CMC
Quality & Compliance
Regulatory
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 CGT. 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.
Heather finds that an initial starting point for many DHC clients involves identifying and formalizing the necessary elements to their development plans. This can take the shape of a Gantt chart, a roadmap to commercialization, or a project plan, to name just a few. Once these plans are formalized, she moves on to assisting clients in executing against those plans. Tech transfers are one of her areas of particular expertise, as are program management needs such as project management regulatory support, relationship management, and vendor/CDMO management.
Heather’s pre-DHC professional career began after earning her M.S. in Pharmacology and Toxicology, when she went to work in R&D at Chiron and Novartis, developing next generation clinical diagnostic immunoassays for HIV and Hepatitis. After that, she transitioned into project management to support the technical operations and cross-functional CMC teams at Novartis Diagnostics.
After 15 years at Chiron/Novartis/Grifols, Heather then 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.
Then, 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.
In 2017, Heather then joined Orchard Therapeutics. There, 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.
Her most recent pre-DHC experience occured when 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.
Gritstone Oncology (now known as Gritstone Bio)
Director CMC Project Management
Orchard Therapeutics
Associate Director CMC Project Management
Dynavax Technologies
Associate Director Tech Ops (CMC Project Management)
Sangamo Therapeutics
Senior Project Manager, Tech Ops
Chiron/Novartis/Grifols
Senior Project Manager, Tech Ops
Project Manager, Tech Ops
Research Specialist, R&D
Research Associate, R&D
University of California, Davis
M.S., Pharmacology and Toxicology
University of California, Los Angeles
B.S., Biology with an emphasis on Ecology, Behavior, and Evolution
