Susan Sun

About Susan Sun

Built an integrated in region team from scratch to 9 people, establsihed and implemented the strategies for the overall analytical support to Merck internal sites and external CMOs in Asia Pacific (AP) region for commercial products, be accountable to establish and refine the supporting model that fits for the region and continue improving it to maximize the business opportunities in the region. Manage and develop the AP team to support the internal sites and external CMOs in the region to ensure continuous supply to meet the dynamic global market demands. Activities include but not limited to investigations, regulatory CMC activities, tech transfer, regulatory inspection, test on importation, new technology implementation, cost saving and efficiency improvement, capability building, etc Represent analytical function to lead and serve on various cross functional teams to support NCE program development and launch at Merck. o Manage projects ranging from phase I to launch. o Collaborate with multiple functional areas including stability, pre-clinical and clinical, formulation design, process engineer, marketing, packaging, supply chain, CMC, local regulatory affair, quality, internal manufacturing sites and external CMO/CRO partners to support product development and launch. o Serve as the key member of the Integrated Development & Supply Team for late phase projects, lead cross functional Analytical and Quality teams to support projects for successful registration, approval and launch. o Serve as the technical leader of the Due Diligence team, evaluate potential business deals or acquisition for in license NCE/products or potential partners for collaboration/joint venture. Lead the analytical team from Emerging Market Center of Excellence (EM COE) within Merck. o Develop and implement EM product development strategies across Merck with strong leadership and influencing skills. o Lead the overall analytical support for product development activities at local sites, internal development hubs, development partners, CRO/CMO for Emerging Markets. o Gained working experience and knowledge of regulatory requirements and expectations from the emerging markets (BRICK countries and Japan). In particular extensive working experience with China FDA via direct and indirect interactions with the China HA.

Experience

1. Director

   Merck

   Jan 2016 — Present · Shanghai City, PA, US

   Built an integrated in region team from scratch to 9 people, establsihed and implemented the strategies for the overall analytical support to Merck internal sites and external CMOs in Asia Pacific (AP) region for commercial products, be accountable to establish and refine the supporting model that fits for the region and continue improving it to maximize the business opportunities in the region. Manage and develop the AP team to support the internal sites and external CMOs in the region to ensure continuous supply to meet the dynamic global market demands. Activities include but not limited to investigations, regulatory CMC activities, tech transfer, regulatory inspection, test on importation, new technology implementation, cost saving and efficiency improvement, capability building, etc.

Education

• University of Tennessee

  Master of Science, Analytical Chemistry

  1995 — 1998

• Fudan University

  B.S., Chemistry

  1987 — 1991