Su Chen Email & Phone Number

Chengdu, Cn

Chengdu, Sichuan, China

Set up and operated a startup biotechnology company developing innovative drugs in oncology, autoimmune diseases and infectious diseases for global markets.

Chengdu, Sichuan, China

• Held multiple meetings with FDA and European agencies and finalized the Conbercept (an innovative fusion protein independently developed by the company) global phase III clinical development plan. Filed INDs in 35 countries/regions and a special protocol assessment (SPA) application for one of the global protocols with FDA, and obtained all permissions.• Initiated and led two parallel multi-region double-blinded pivotal global trials for Conbercept starting in 2018. Made executive decisions to timely resolve escalated issues; Provided guidance and managed activities in regulatory submissions, CRO outsourcing, vendor management, supply chain management, change control, budget control and quality management; • Managed 2 global phase III studies. Completed the recruitment of over 2300 patients in 30 countries and reached study primary endpoint ahead of schedule. Reviewed and approved over 300 clinical trial agreements (CTA), maintained sufficient oversight and connections with study sites around the world during the Covid-19 pandemic to ensure the safety of patients and staff. • Managed the R&D group and obtained multiple Chinese ANDA, NDA and SNDA approvals for new indications and CMC change of existing products.

Beijing, China

• Negotiated with various agencies and obtained their endorsement and permits for building a new biologic manufacturing site in Beijing.• Hired and developed a new team of cross-functional professionals and managed daily activities; Completed thorough conceptual and detailed designs of the over 100,000 m2 state-of-the-art new biologics manufacturing facility; • Customized and ordered production systems from global top-notch suppliers, negotiated with and appointed contractors, established and controlled budgets, set up quality systems, and managed construction timeline. • The new facility was on schedule to start commissioning and qualification by the end of 2020 amid Covid-19 pandemic. Pending on the filing and approval of a new BLA with US FDA and EMA, this facility is positioned to launch products in the US, EU and other markets within 2-3 years.

Jinan, Shandong, China

• Established corporate multi-year strategy and execution plan to grow the biopharma division and product pipeline.• Provided leadership and technical guidance to the team of 500 people in the areas of process development, quality management, engineering and regulatory filing to meet product development goals. Obtained multiple IND approvals from the Chinese FDA. • Led the stage 1 construction of a new commercial biologics manufacturing facility totaling over 150,000 m2. Provided technical guidance and made key decisions in a very fast-paced environment for plant and equipment design, GEP and GMP system development, automation system development, commissioning and validation, and product transfer. • With my leadership and effective multi-disciplinary collaborations, the new plant took slightly over one year to complete mechanical construction/installation and commissioning from groundbreaking, setting a record in the industry.

Chengdu, Sichuan, China

• Managed the R&D group and pipeline development across small molecule, herbal medicine and biologic drugs. Managed quality improvement initiative across the company. • Obtained late-stage clinical IND approval from Chinese FDA and advanced multiple large-scale oncologic clinical studies.

Chengdu, Sichuan, China

• Hired and trained a team of over 300 professionals to complete CMC development for an innovative fusion protein (Conbercept) for launching in the Chinese market. Obtained marketing approval for Conbercept with retina indication from the Chinese drug administration in November 2013 and passed GMP inspection in December 2013. Led post-market CMC change development and obtained regulatory approval in 2017.• Completed the construction and commissioning of a cell culture manufacturing facility according to the global GMP regulations at a fraction of the comparable US site cost. Managed and improved the quality system and manufacturing operations and prepared the new facility for a PAI. Enforced a corporate quality culture such that every day and every activity must remain compliant.• Set up a pharmacovigilance system to monitor post-market safety issues. Led and completed large-scale post-market safety studies to enrich the product safety profile in a real-world setting. Audited and approved material suppliers and product distributors and managed country-wide cold-chain distribution network. • Reached out to multinational companies and negotiated the potential licensing deal for the development and launching of Conbercept in foreign markets. • Organized multiple pre-IND meetings with US FDA and prepared for regulatory filings.

San Francisco, California, United States

• Led a manufacturing network consolidation project as part of a multi-billion dollar Biotech M&A transaction. Developed a network rationalization strategy to drive immediate cost synergies. Created operational plans to transfer products across a network comprising of over 10 impacted factories. • Developed an M&A supply chain integration playbook for a major biopharmaceutical company based on the best practices and expert knowledge. • Analyzed and identified $40M in annual cost saving opportunities in the R&D division for a mid-size biotech firm. Assessed R&D projects in the portfolio and prioritized cost saving initiatives. • Set up and managed a project management office (PMO) for a cross-functional engagement with a leading biotech firm. Built a roadmap for setting up an enterprise-wide Information Management system.

Vacaville, California, United States

• Managed the manufacturing science arm for a 4-year, $750M, 8x25000L cell culture plant expansion project (CCP2) with the responsibility of ensuring timely licensure of the new facility.• Provided technical leadership in equipment design review, risk management (FMEA and CAPA), technology transfer, operations, validation, planning and regulatory compliance. • Championed efforts to shorten startup time between mechanical completion and the first successful trial run by 3-5 months representing a saving potential of $30M, as a result of proactive risk management, project prioritization, and cross-functional partnership.• Approved automation recipes and cGMP manufacturing procedures; Directed troubleshooting efforts and approved changes under the phase gate review and change control process. • Defined sub-project plans, timelines, resources, constraints and acceptance criteria; Tracked, controlled and reported project progress and risks. • Participated in department annual budget setting and managed contractor spending account. • Evaluated financial impact and operational issues associated with process improvement initiatives.• Recruited and developed a team of technical experts; Set individual SMART goals and provided ongoing performance coaching; Established a collaborative and innovative team culture.

Redwood City, California, United States

• Managed a team of cross-functional experts for concurrently performing process development and manufacturing activities; Ensured that day-to-day operations in the pilot plant and manufacturing facility were quality and safety compliant.• Led performance improvement projects that resulted in an 8-fold increase in operational efficiency and a 3-fold reduction in production cost, through technical innovations and the application of proven Lean methodologies like 5S, DMAIC, SMED, Kaizen, Kepner Tregoe, and etc.• Launched three E. coli based recombinant products to business partners and exceeded project timeline, cost and quality expectations.• Developed a product supply strategy for the management team; Managed technology transfer and CMO activities.

Berkeley, California, United States

• Led cell culture process development and cGMP clinical manufacturing activities and enhanced both process robustness and operational efficiency.

Pleasanton, California, United States

• Developed components for a web-based ERP package; Provided customer supports.

Emeryville, California, United States

• Developed, scaled up and optimized a total of seven mammalian cell culture, E. coli and yeast high-yield processes at laboratory (1-20L), pilot (20-100L) and manufacturing (500-10,000L) settings. • Developed and optimized downstream processes for extra cellular and intracellular antigens using centrifugation, cross flow filtration, and chromatography technologies.• Produced cGMP materials and led efforts in troubleshooting problems and variances encountered during manufacturing.• Prepared CMC section for regulatory filing and supported inspection preparations.• Published novel process model and developed new technologies to address issues in process optimization, automation and rapid product development.

La Jolla, California, United States

• Managed daily activities of a multi-million dollar bioprocess facility; Developed annual budget and operational plan under the direct leadership of the Chief Operating Officer. • Developed pilot-scale E. coli, yeast and sf9-based processes to produce and purify biologics for research use.

Mba, Business Administration

Ms, Computer Science

Ms, Chemical Engineering