Experience

Orchard Therapeutics

• United Kingdom
• Biotechnology
• 100 - 200 Employee

• Associate Director, IT Business Analyst

  • Feb 2022 - Apr 2022

  San Francisco Bay Area

• Associate Director, Global Supply Chain

  • Jan 2021 - Feb 2022

  San Francisco Bay Area Cell therapy technical expert in Global Supply Chain group. Developed site qualification processes. Led the successful qualification of two clinical study sites and five commercial treatment centers. Authored clinial and commercial Product Manuals.

• Associate Director, Cell Therapy Operations

  • Aug 2017 - Jan 2021

  Foster City, CA Led a global tech transfer and manufacturing support team and worked closely with internal clinical operations, commercial operations, quality, supply chain, internal business development, and procurement groups, and external stakeholders to ensure successful delivery of drug product to patients. • Led drug product process development for a late-stage cell and gene therapy program. • Authored and reviewed drug substance and drug product sections of US and EU regulatory… Show more Led a global tech transfer and manufacturing support team and worked closely with internal clinical operations, commercial operations, quality, supply chain, internal business development, and procurement groups, and external stakeholders to ensure successful delivery of drug product to patients. • Led drug product process development for a late-stage cell and gene therapy program. • Authored and reviewed drug substance and drug product sections of US and EU regulatory applications • Contributed to drug product development strategic planning for early and late-stage cell therapies. • Tech transferred manufacturing processes from internal development lab to external manufacturing facilities. • Tech transferred manufacturing processes acquired from external developers into internal process development lab • Provided on-site support during manufacturing campaigns at external CDMOs. • Performed process risk assessments and deviation investigations, design and implement CAPAs. • Received a Roots and Shoots Award for going above and beyond in service of the company’s values.

• Manager, US Cell Therapy Operations

  • Feb 2017 - Aug 2017

  Foster City, CA Led drug product manufacturing tech transfers to two CDMOs and the Process Development team. • Trained CDMO manufacturing team on process execution. • Designed and executed development experiments. • Tech transferred manufacturing processes from academic manufacturing centers to internal development lab. • Identified areas for improvement in manufacturing processes. • Developed master manufacturing batch records. • Reviewed executed production documentation. • Set up and… Show more Led drug product manufacturing tech transfers to two CDMOs and the Process Development team. • Trained CDMO manufacturing team on process execution. • Designed and executed development experiments. • Tech transferred manufacturing processes from academic manufacturing centers to internal development lab. • Identified areas for improvement in manufacturing processes. • Developed master manufacturing batch records. • Reviewed executed production documentation. • Set up and managed the Process Development lab, including equipment qualification and calibration programs. • Provided safety orientation for new lab employees.



Sangamo Therapeutics, Inc.

• United States
• Biotechnology Research
• 200 - 300 Employee

• Process Development Associate IV

  • Jan 2016 - Dec 2016

  Richmond, CA I work on scaling up and optimizing enrichment, gene editing, and cryopreservation processes for manufacturing autologous cell therapies to support clinical trials.I also: --Perform tech transfer activities --Supervise day-to-day laboratory work --Coordinate with CROs to complete toxicological studies --Collate and analyze data --Write, edit, and review batch production records and SOPs

• Process Development Associate III

  • Jun 2015 - Jan 2016

  Richmond, CA I work on scaling up and optimizing enrichment, gene editing, and cryopreservation processes for manufacturing autologous cell therapies to support clinical trials.I also: --Perform CMO tech transfer activities --Supervise three direct reports --Supervise day-to-day laboratory work --Coordinate with CROs to complete toxicological studies --Collate and analyze data --Write, edit, and review batch production records and SOPs



Cellerant Therapeutics

• Manufacturing Associate II

  • Mar 2013 - May 2015

  Same as below, plus: • Train new personnel on routine processing and other lab activities • Provide basic support and training for commonly used laboratory instruments (AutoMACS, HemaVet CBC analyzer, etc.) • Travel to CRO to supervise preparation of cell therapy drug for in vivo studies

• Manufacturing Associate I

  • Aug 2011 - Mar 2013

  San Carlos, CA • Perform routine tissue processing and cell culture to support R&D and Process Development activities • Write and execute process development experiments including scale-up, technology platform comparisons, and culture condition optimization • Analyze data from process development experiments and report results • Support tech transfer activities between R&D and Process Development, and convert PD protocols into GMP SOPs and batch production records • Perform routine lot… Show more • Perform routine tissue processing and cell culture to support R&D and Process Development activities • Write and execute process development experiments including scale-up, technology platform comparisons, and culture condition optimization • Analyze data from process development experiments and report results • Support tech transfer activities between R&D and Process Development, and convert PD protocols into GMP SOPs and batch production records • Perform routine lot characterization assays including FACS phenotype analysis • Manage inventory of cryopreserved cells shared by several departments • Provide raw data and analysis to multiple departments upon request • Coordinate domestic and international cell shipments to CROs, manage shipping permits and licenses • Assist in designing and implementing controlled systems for in-house studies that support GMP activities • Write SOPs, material specifications, and technical protocols • Review completed GMP batch records and QC testing reports • Coordinate sterility, endotoxin, mycoplasma, and viral testing of samples at contract laboratories



StemCells Inc.

• Manufacturing Associate

  • May 2010 - Aug 2011

  Expanded and banked human neural stem cells in a Class 10,000 cleanroom; produced clinical product from banked cells; formulated growth medium and reagents; trained Manufacturing personnel on procedures and SOP revisions; trained clinical site personnel in Zurich, Switzerland on shipping and product handling protocols; wrote and executed equipment validation protocols; wrote and revised SOPs, MPRs, equipment specifications, etc.; wrote deviations, equipment change control requests, and… Show more Expanded and banked human neural stem cells in a Class 10,000 cleanroom; produced clinical product from banked cells; formulated growth medium and reagents; trained Manufacturing personnel on procedures and SOP revisions; trained clinical site personnel in Zurich, Switzerland on shipping and product handling protocols; wrote and executed equipment validation protocols; wrote and revised SOPs, MPRs, equipment specifications, etc.; wrote deviations, equipment change control requests, and investigations as necesssary; maintained process and material/reagent information databases; performed process qualifications and documented results in final reports Show less



Juvaris

• Research Assistant

  • Sep 2009 - Apr 2010

  · Isolated and processed PBMCs from human blood samples for a Phase II clinical trial · Performed assays including ELISA, HAI, and Microneutralization · Murine splenocyte harvesting and processing, saphenous bleeding, cardiac bleed, serum collection and processing, intramuscular injection, weight monitoring, and facility maintenance



Cognate BioServices, a Charles River Company

• United States
• Biotechnology Research
• 1 - 100 Employee

• Cell Production Associate

  • Feb 2009 - Aug 2009

  · Continued performing facility operations tasks · Performed sterile culture, cryopreservation, and shipping of human dendritic cells and CD34+ cells for clinical use · Isolated tumor proteins from human tumor tissue · Documented GMP processes on BPRs and equipment use logs, followed and reviewed SOPs · Expanded and maintained human BMSCs in culture

• Operations Associate

  • May 2008 - Feb 2009

  · Monitored equipment and performed preventative maintenance · Acted as verifier for GMP processes · Performed manual and automated cell counting · Handled liquid nitrogen (LN2), CO2, dry ice, and biohazardous waste disposal · Stocked and organized laboratories



Clemson University

• United States
• Higher Education
• 700 & Above Employee

• Graduate Assistant

  • Aug 2005 - May 2007

  Insect identification for an environmental monitoring project



The Academy of Natural Sciences of Drexel University

• Museums, Historical Sites, and Zoos
• 1 - 100 Employee

• Summer Intern

  • Jun 2005 - Aug 2005

  Assisted with field work, sample processing, and data analysis for a stream ecology project