• Extensive experience in developing scientific content, regulatory submissions, technical documents, and successful grant proposals for discovery and clinical programs.
• Expertise in cell and gene therapy, biologics, and oncology product development.

• Served as an integral member of executive management overseeing the comprehensive development of cell therapy product candidates, spanning from conception and basic research to IND submission.
• Spearheaded the development and implementation of project strategies, plans, timelines, budgets, and other necessary activities to ensure project success.
• Led product development efforts for the Oligodendrocyte Progenitor Cell (OPC1) and Auditory Neuron Progenitor Cell (ANP1) programs, and allogeneic dendritic cell vaccine for non-small cell lung carcinoma.
• Effectively managed departmental budgets and staffing requirements.
• Facilitated cross-functional communication and fostered contributions across all development programs.
• Contributed to business development initiatives, including both in-licensing and out-licensing activities.

• Spearheaded the development of an immunotherapeutic vaccine program targeting metastatic ovarian cancer, melanoma, glioblastoma, and COVID-19.
• Oversaw relationships and contract execution with Key Opinion Leaders (KOLs), consultants, and Contract Research Organizations (CROs).
• Championed operational excellence across multiple projects, playing a pivotal role in shaping the company's business and strategic direction.
• Secured over $20M in funding, including State and Federal grants totaling approximately $6M.
• Managed R&D operational budgets and personnel, encompassing hiring, training, and merit recognition.
• Directed project management of private, state, and federal grants, ensuring timely achievement of operational and financial milestones.
• Innovated novel topical cell-based skin products under the brand Root of SkinMD, comprising 6 SKUs, and established a robust distribution network alongside a structured sales and marketing strategy.
• Provided technical and scien

• Successfully secured over $22 million in grants, including a $17.7 million CIRM grant, SBIR grant, and NIH grant. These funds supported Phase III clinical trials and research into the mechanism of action of an immunotherapeutic program aimed at treating patients with stage III recurrent or stage IV metastatic melanoma.
• Managed all aspects of budgeting, timelines and deliverables for the R&D department.
• Led the design and coordination of proteomic, genomic, and epigenetic studies to elucidate mechanism of action studies. Acted as the technical expert on science and technologies utilized in these assays.
• Analyzed and interpreted mechanism of action data focusing on prognostic and predictive biomarker identification. Utilized findings to develop a clinical diagnostic test for potential partnering opportunities.
• Prepared documentation for the FDA, and EMA submissions.
• Pioneered the development of a potency assay for the metastatic melanoma immunotherapeutic program.
• Fac

• Defined and executed the pre-clinical activities necessary for IND submission for one Phase II ovarian cancer trial and one Phase III metastatic melanoma trial, both based on dendritic cell immunotherapy platform technology.
• Harmonized the patient tumor collection and the specimen delivery to the manufacturing site.
• Established the cell manufacturing protocol for the Phase II ovarian cancer trial.
• Optimized melanoma tumor cell line manufacturing process using Lean Six Sigma methods to reduce the cost and better streamline the manufacturing procedure.
• Formulated clinical product scale-up.
• Planned and coordinated studies necessary for new product development.
• Evaluated technology for IP filing and directed patent submissions.

• Directed commercialization of several stem cell-derived cellular products and culture support products (media, supplements) to a major cell product distribution partner.
• Spearheaded product development, optimization, and validation in partnership with the distribution partner.
• Provided customer and scientific support to high-level biotechnology and pharmacology companies and traveled to their site to provide customized support.
• Implemented a new training program for the sales team to increase sale productivity.
• Created marketing and sales material.

• Implemented new protocols for hESC differentiation into clinically relevant motor neuron progenitors and other high-purity differentiated cell types.
• Authored several publications and patents around neuron differentiation from pluripotent stem cells.
• Developed a clinical study protocol that led to successful IND submission for a Phase I clinical trial of human embryonic stem cell-derived cellular therapy for Spinal Muscular Atrophy (SMA) Type 2.

• Designed and managed a stem cell BSL2+ culture facility.
• Isolated several hESC lines and generated master and working cell banks of clinically relevant hESCs.
• Implemented cGMP manufacturing processes.

• Discovered a crucial role of the progesterone receptor in mediating breast cancer development in Brca1mutation carriers and published these results in Science.