Xianglei Meng Email and Phone Number

• Process Engineering expertise input to the Drug Product Development teams•Due diligence assessments of CMO for clinical trial material manufacture, including equipment and facility assessments to confirm capability for formulation, fill finish and clinical packaging.• Support optimizations and/or changes to existing equipment• E2E responsibility for the manufacture of clinical trial material meeting the clinical demand schedule.• Tech Transfer support includes commercial plant readiness for registration, launch and commercial production, DoE & Scale-up support

• Providing technical support for External pharmaceutical manufacturing network to ensure operational excellence, product quality, and optimal product flow to respective markets. Works with the regional/global commercial sites to facilitate new and in-line technology transfer and commercialization projects.• New Product Introduction (NPI) / Life Cycle Management (LCM)• Issue / review tech transfer strategy, validation plans, protocols and reports• Execute the tech transfer, process characterization runs in the field and / or oversee the execution at EM sites• Lead investigations on the site by providing technical expertise (process, packing, cleaning...)• Provide process / technology input to SOP’s, Master Batch Records and change controls• Partner with Engineering & Maintenance and contribute to equipment changes / introduction projects on the site• Perform process development as part of process improvement (scale up, equipment transfers, performance improvement, packaging development, etc.…)

• Support department head to meet project timelines, department goals, and customer requests for formulation development, clinical manufacturing, packaging, labeling, technology identification, due diligence.• Lead the efforts for the formulation development, scale up process for solid, liquid, parenteral and other formulations as needed for preclinical development, first in human (FIH) formulation development, clinical phase development, platform selection, late stage development for NCE’s from various global client’s• Review development protocol, stability evaluation protocol, and related summaries/reports for technical & regulatory compliance• Key point of contact with internal and external stakeholder to brief them on technical status of projects and track project progress• Lead and execute efforts from lab investigations scales to clinical trial material manufacturing under GMP for various clinical phases (US, EU, CN IND batch manufacturing)• Plan, co-ordinate, and oversee the work activities of scientific staff within the group. Involved in the daily management of equipment and pilot facility scheduling for different projects• Perform daily management of the formulation development lab; Conduct the group training in development technologies and compliance as needed• Interact with different departments within organization for CMC/integrated projects to support client need include process chemistry, pre-formulation, analytical development, stability team, DMPK, Quality Assurance• Review IQ/OQ/PQ protocols, process validation plan, CAPA/investigations, formulation development report, and/or summaries/reports related to formulation and process development work• Provide forecast of new technology needs, budgeting, technology implementation and timelines to department head