Chris Sun PhD PMP

In my most recent role, I managed operations of PMO, guided portfolio planning, prioritization, and governance across cell and gene therapy programs. As a central coordination and escalation authority for client engagements, I aligned internal stakeholders, clinical operations, manufacturing, and quality functions to support cGMP delivery. Some of my contributions are: • Enabled successful delivery of 30+ cGMP cell and gene therapy manufacturing campaigns and 15 process development programs, supporting clinical supply continuity and milestone adherence. • Accelerated site activation and final product lot disposition through close coordination with Clinical Operations, Manufacturing, and Quality teams. • Strengthened executive decision-making and global risk visibility by designing and deploying Smartsheet-based project dashboard consolidating inputs from teams across Japan, Germany, and the U.S., enhancing portfolio transparency and governance effectiveness.

As a Project Manager, I directed project execution for live biotherapeutic manufacturing programs, offered executive-level portfolio updates and performance insights through Smartsheet dashboards, enabling visibility into timelines, risks, and financial status. My accomplishments: • Contributed to the successful execution and close-out of 20+ non-GMP and 5 cGMP manufacturing campaigns, maintaining compliance with internal quality and client expectations. • Strengthened cross-functional alignment and delivery reliability by establishing structured communication workflows across manufacturing, fermentation, and quality teams. • Improved financial transparency and forecasting accuracy through disciplined budget tracking, quotation preparation, and portfolio-level financial reviews. • Increased leadership visibility and operational efficiency by designing and implementing Smartsheet-based dashboards and automated reporting solutions.

Streamlined operations of preclinical efficacy team, overseeing animal studies in oncology, fibrosis, NASH, cell-based assays, and immunology/virology. Partnered with cross-functional teams, including scientific, operational, and business development personnel to ensure study execution, compliance, and client deliverables. *Notable Achievements* • Successfully executed and closed 100+ preclinical animal studies across oncology, fibrosis, NASH, and virology, maintaining high standards of scientific rigor and compliance. • Enhanced team performance and collaboration by organizing and leading cross-functional meetings supporting business development, proposal preparation, and operational efficiency.

Championed small-molecule development and clinical programs in cardiology, urea-cycle disorders, ALS, and vulvovaginal atrophy. Steered cross-functional teams to execute clinical development plans, support technology transfer, and manage regulatory submissions. • Completed technology transfer and manufacturing setup for a urea-cycle disorder drug candidate in China, supporting subsequent regulatory approval. • Spearheaded multiple drug development and registration programs across ALS, urea-cycle disorders, and vulvovaginal atrophy, enabling successful filings in Hong Kong and China.

On a daily basis, oversaw execution of multiple oral chemotherapeutic formulation development programs. Leveraged strong leadership skills, steered junior staff and monitored progress of preclinical development projects. • Completed multiple government-funded oral chemotherapeutic development projects in Hong Kong and Macau, enabling IND Phase I clearance for breast cancer, NSCLC, and GBM treatment regimens. • Boosted preclinical program efficiency and oversight via structured project planning and milestone tracking. • Directed preparation of drug product stability, GLP toxicology, and pharmacokinetics studies, ensuring compliance with regulatory standards and scientific rigor.

Managed daily operations for multiple assay development and validation projects, specializing in Anti-Drug-Antibody (ADA ELISA) assays across mouse, rat, and dog models. Oversaw GLP and non-GLP animal studies conducted at CROs. • Managed and ensured quality of multiple GLP and non-GLP animal studies, facilitating accurate reporting for IND submission packages. • Successfully coordinated the CTA submission of a drug candidate, resulting in regulatory approval to initiate clinical studies in the UK. • Mentored and guided team members, enhancing research productivity and professional growth.