Nicky Zhou, MSc, PMP®

Drug Modality Focus - Small Molecule · Conduct daily review of technical proposals (R&D, clinical, tech transfer) for clients with a focus on risk mitigation and translate to work breakdown structures with Gantt Chart, resulting in clients winning proposals · Manage formulation, analytical development and clinical projects from research and development (Phase I, Phase II, tech transfer), completing manufacturing of drug products within timelines · Manage projects with large budgets and construct project scopes to enhance risk and resource management, delivering all projects within expected timelines and leading to additional projects from clients · Facilitate client visits and present comprehensive project updates (in-person, virtual) to align with organizational needs, improving client relations and securing drug development manufacturing project · Spearhead critical projects from planning to completion, generating highest monthly revenue for company and receiving 3 client appreciations within 1 year time frame

Drug Modality Focus - Gene Therapy · Mitigated project roadblocks, organized video conferences to spearhead open communication with stakeholders, and forecasted risks using analytics, securing new clients, supporting growth in annual revenue, and leading to acquisition of Houston manufacturing facility (3X larger than current facility) · Coordinated project planning activities, set agendas, defined timelines, and built budget forecasts for 3 clients, supporting clients from conception to IPO and resulting in client raising 9 figures in Series B financing · Enhanced client portfolio, managed strategic technical consultation services (plasmid design, AAV manufacturing), and delivered analytical assay expertise, contributing to a successful project bid · Oversaw revision and implementation of SOPs to follow GDP guidelines and ensure compliance with CAPAs, achieving 100% client retention rate for 40+ clients for GxP manufacturing projects with stringent analytical demands · Led internal capacity for audits and accreditation and oversaw laboratory management, facilitation of equipment calibration, and preparedness strategies, playing a key role during a successful audit in 2022

• Improved upstream cell culture of AAV manufacturing and downstream purification schedule efficiency, completing 500+ cell culture production runs and averaging 5+ GLP projects annually • Translated cell culture and purification laboratory data into SOPs to optimize training, onboarding, and manufacturing processes, decreasing new employee onboarding from 3 months to 2 months and maintaining compliance with GDP • Optimized production process and material supply to ensure supply levels aligned with proposal estimates, decreasing drug development costs by 10-20%

Partnering with Hostel HI USA, Beyond Borders Storytelling workshop has been around the bay area for six years and helped hundreds of teenagers fulfill their traveling dreams. Founded by Will, Justina, and Megan, Beyond Borders storytelling workshop is a unique experience for everyone who has a dream to become a better storyteller and make an impact on society. It is my first time on stage at Piano Fights' local bar. I will never forget the experience to connect with the audience. Especially the friendship I gained from the workshop and the donation we contributed to the traveling grant.

Drug Development Stage - Preclinical (In Vivo) • Spearheaded development of protocols and study designs for pharmacokinetic and toxicity studies on mouse or rat models, completing 24+ projects within 6-month timeframe • Garnered extensive expertise in handling small/large molecules within the domains of oncology, infectious disease, and immunotherapy, ensuring accurate and critical updates on project progress

Drug Development Stage - Preclinical (In Vivo and In Vitro) • Lead technician for 15 studies conducted on the mouse model in a BSL II environment that accesses drug toxicity, efficacy, and model development on Chimeric Antigen Receptor (CAR) T cell studies, type I diabetes, cancer (ovarian, lung, breast, lymphoma, sarcoma, skin), Huntington's disease, and muscular dystrophy, achieving zero deviations on study activities and securing promotion from entry-level to mid-level due to excellent performance • Successfully demonstrated study activities in drug formulation, experimental design, agent injections, tumor measurements, and data presentations • Implemented cell isolation, cell proliferation (continuous and finite), aseptic technique, and cell cryopreservation

Research area focus - Immunology and Microbiology

The curriculum covers the following area: Module 1: The landscape of artificial intelligence in the pharmaceutical industry Module 2: Using AI for early drug discovery: From small molecules to biologics Module 3: Modeling the biological underpinning of disease Module 4: Biomarkers, discovery, and patient stratification Module 5: Design and management of clinical trials Module 6: Business and innovation in pharma

Actively attended group meetings when preparing the first graduate symposium and provided ideas to help the first symposium succeed. Advertised the symposium and received 180 participants from 85 graduate programs.

A leader in the college volunteer team. Helped to build up a new department in the team. Organized activities to visit seniors and provide daily care. Volunteered in the 2010 Asian Games. Accomplished a two-year university student innovation project. Found the most effective antibiotic bacterium and completed the student thesis of the project. Worked in the microbiology lab for three years. Accomplished thesis in immunology area.