University of Nottingham

Anhui University

Senior Director, Process Development at Tmunity Therapeutics Incorporated

With more than 20 years of experiences in cell therapy including cell process development, technology transfer, new product launch, clinical manufacturing, regulatory filling and support. My accomplishment included design, develop and launch multiple cell manufacturing platforms for start-up biotechs which enabled the clinical manufacturing capability.  I am an extremely flexible person that has a can-do attitude, be it in the lab or lead a group, you can count on me.

Resilience

Senior Director

Tmunity Therapeutics Incorporated

Senior Director, Process Development

Leader Process Development

Adaptimmune

Technical Director, US Manufacturing

Direct the manufacturing of cellular product to support Phase I and II clinical trials. 

Major responsibilities:
1. Oversee the daily GMP manufacturing activities. 
2. Coordinate product testing, product release for infusion.
3. Work with the Translational Research Operational Directors to establish new trials. Participate in site initiation visit.
4. Manage and coordinate with the Clinical Trial Units and CRO for study subjects’ cell manufacturing schedules to ensure a smooth transition of cell product from patients’ clinical site into manufacturing site.
5. Perform regular manufacturing capacity planning and forecasting by coordinating with the different project sponsors to ensure product is manufactured and delivered on timely basis to meet clinical needs.
6.Maintain cost effectiveness and usefulness of the laboratory; work with senior leadership to develop annual resource budget and strategic plans.
7.  Interface with quality control, quality assurance and regulatory affairs to comply with established policies.
8. Interact with colleagues in and outside the core facility as well as external to the University of Pennsylvania to establish good collaborations.

University of Pennsylvania

Technical Director

Manage and supervise manufacturing of cellular product for Phase I/II Clinical Trials.

Major responsibilities
1. Manage and supervise T-cell manufacturing for Phase I/II Clinical Trials. 
2. Mentor staff technologists in the development of scientific competence related to the manufacturing process for cGMP clinical products.
3. Participate and organize trial site initiation meetings and present manufacturing data to principal investigators and clinical teams 
4. Coordinate with process development, QA, QC, and project sponsors for the transfer of new processes into the manufacturing facility, generate SOPs and batch records.
5. Execute independent research projects, develop project milestones and deliverables. Maintain high levels of scientific and functional excellence.
6. Conduct validations prior to trial initiation in both small and large scales, developed the process for the manufacturing of T-cell cells for gene therapy trials, develop specifications for the quality control tests including: scFv analysis by flow cytometry, BSA, p24 detection by ELISA, test expansion for the eligibility approval.
7. Lead for a multi-sites clinical trial for GBM and serve as CMO for a biotech company with over 120 subjects participated in the trial. Prior to trial start, developed closed system for manufacture dendritic cell vaccines in large scale. Coordinated with CRO for apheresis collection, transportation, manufacture, IP release and shipping to the participating sites; participated in the weekly tele-conference, developed SOPs and Batch records,  conducted short and long-term stability of IP. Trail completed in a year.

Research Project Manager

Manufacture of cellular products under GMP to support Phase I/II clinical trials. Skills include large scale production of T-cells and Dendritic cells,  positive and or negative selection of T-cells from cancer and HIV patients using magnetic beads, transduction of T-cells using lenti or retroviral vectors, T-cell culture expansion using WAVE bioreactors, large scale magnetic bead removal with Baxter Max-Sep, harvest T-cells using Heamonetics Cell Saver, and cryopreservation of cells in bags and vials with the controlled rate freezer. Shipping biological product with LN2 dry shipper according to IATA and DOT regulations. SOP development, batch records review.

Zoe Zheng