Jerrod Denham Email & Phone Number

San Francisco, California, Us

Buffalo, New York, Us

San Diego, Ca, Us

I worked with a cross-functional team at Resilience to build best-in-class cell and gene therapy contract manufacturing capacity throughout North America.

Alachua, Florida, Us

Ology Bioservices, Inc. was acquired by Resilience in April 2021.

Walnut Creek, California, Us

Worked with over 70 different clients at DHC including small virtual start-ups to very large pharmaceutical companies and everything in between. Products include cell therapies, viral vector genetically modified cell therapies, gene edited cell therapies and viral vectors (AAV and LVV). Phase of development was Pre-Clinical to Phase 3/Commercial. Primary focus was Process Development, Manufacturing and CMC Regulatory, but learned a lot with respect to Quality, Program Management and Analytical Development. Supervised as many as 4 Consultants and Senior Consultants within the Practice.

Newark, Cafilfornia, Us

Directed manufacturing sciences and process engineering functions in support of troubleshooting current Phase 2 manufacturing process and development of upcoming Phase 3 commercial manufacturing processes for age related macular degeneration (AMD) and chronic spinal cord injury clinical trialsDeveloped and tech transferred reduced waste clinical delivery system and method for AMD Phase 2 clinical trialProvided leadership and direction on key FDA CMC amendments in support of Phase 2 clinical trials

San Diego, Ca, Us

Directed process development and engineering functions including staff, facility and budget as they relate to cell and combination product manufacturing processes.Developed statistical process control methods to develop, implement and maintain robust and repeatable cell manufacturing processes.Provided leadership and direction on key CMC projects and issues as they relate to cell manufacturing including authoring of cell manufacturing and process development sections of briefing documents for FDA and OUS meetings.

Supervised 2 engineers who provided process engineering, troubleshooting and technical support for human embryonic stem cell derived therapeutic drug products.Established automated tracking and trending programs for Pilot and cGMP upstream and downstream cell therapy drug product manufacturing using JMP software. Collaborated with key internal stakeholders to develop at-scale purification process to remove impurities from cell therapy bulk drug substances.Designed and executed experiments using JMP DOE statistical methods to evaluate commercial container closure systems and formulations for cell therapy bulk drug substances and drug products.Managed optimization of dose preparation processes for cell therapy drug products. Identified and evaluated single use hollow fiber tangential flow filtration units for dose preparation of cell therapy products.Led studies to test biocompatibility and stability of prepared drug products with clinical delivery systems including syringes, pumps and catheters. Developed and transferred shipping, receipt, accountability and return procedures for clinical grade drug product.Directed technology transfer of drug product dose preparation process to 7 clinical site bone marrow transplant cell processing laboratories.

Designed and built new pilot plant facility using Lean Six Sigma principles.Managed pilot plant facility and supervised 4 development associates to produce human embryonic stem cell derived products for pre-clinical animal studies, clinical device testing and in vitro research studies.Developed process flow diagrams, wrote technical reports and authored sections of IND for use of the 1st human embryonic stem cell derived product in Phase I clinical trial in acute spinal cord injury. Developed dose preparation process for autologous dendritic cell based cancer vaccine for Phase II clinical trial in patients with Acute Mylogenous Leukemia in clinical remission. Transferred autologous vaccine dose preparation process to 6 clinical site cell processing laboratories.

Technical lead for cGMP production activities to produce human embryonic stem cell derived cellular therapy products.Planned production runs, coordinated resources and sourced raw materials. Developed downstream processes including final formulation, fill and finish, cryopreservation, storage, shipping and dose preparation of human embryonic stem cell derived cellular therapy products.

Los Angeles, Ca, Us