徐笑焱 Email & Phone Number

中国 江苏省

As Suzhou manufacturing operation head, responsible for Car T manufacturing.i. Build a brand-new Suzhou manufacturing team with high execution capability, set tailor-made development plan for their growth, build a good learning and cooperation environment.ii. Lead team successful completed technical transfer. Successfully accomplish water run, media run, APV, PPQ, NIFDC batch in tight schedule.iii. Experience of P2 lab management: Prepare application document and obtains the certification. iv. Develop manufacturing strategy based on business needs. According to forecast, enlarge capacity, build workforce planning and setup new working module and effectively organize, shift arrangement, etc. v. Setup manufacturing training system and skill matrix, ensure the effectiveness and continuous improvement for agility and flexibility of manufacturing process.vi. Build standardizes and reliable manufacturing system. Create and maintain related document: SOPs, MBRs, Logbooks, etc. Ensure product produced within compliance.vii. Lead team successfully completed GMP onsite inspection and obtain GMP certification.viii. Participate BLA application. Provide input and support from manufacturing aspect.ix. Lead GMP readiness, participate PAI for dynamic manufacturing and pass on site inspection.x. Organize clinical manufacturing based on clinical requirement; prepare to launch commercial manufacturing according to business needs.xi. Lead structure meeting in operation team, drive good communication cross-functionally in time, ensure manufacturing Right First Time.xii. Budget management. Lead lean manufacturing for continuous improvement and cost saving.xiii. Lead and participate certain cross functional project: participate project of new technology like lentivirus manufacturing; some automatic system like: MES, SAP, LIMS,COI etc.

Shanghai

Supply cost effective quality products, timely service to the customers and communicate the added value internally as well as to our business partners. Provide leadership for best business practices such as GMP (Good Manufacturing Practice),TPM (Total Production Management) and lean manufacturing in Sterile manufacturing. Develop strategy plan to achieve long range objectives, drive production capacity enlargement. Ensure Safety, Health and Environment and quality compliant requirements are fulfilled in alignment with corporate policy and local legal requirements. Implement and utilize KPIs (Key Performance Indicators) to lead manufacturing organization. Ability to pass these methods to subordinates and team to utilizing key data is highly desired.  Utilize lean six Sigma and other tools to implement continuous improvement to enhance product quality and manufacturing efficiency by identifying improvement opportunity.  Accountable for overall budget and financial performance of Rocephin manufacturing.  As member of Rocephin DPT, and PTSH lead SME of certain GSPs, drive network activities and alignment, cross-functional planning, and decision making. Engage to implement lean manufacturing in the team according to PT behavior. Leader within the Manufacturing Leadership team, Lead sterile manufacturing team with about 45 personnel. Focus on people development, use multi-skill training, tailor-made IDP to expose people with potential different field. Drive the suitable staff and competency within team.  Use PMP method successfully lead certain site projects, Eg. Build workforce planning and competence model. Rocephin Strategy based on E2E Risk Assessment, etc.

Shanghai

As solid flow manger, be familiar with solid manufacturing and packaging process, inherence interdepartmental communication to ensure the whole solid flow (from planning to product delivery) working smoothly.-Lead more than 40 people’s production team.-Optimize production process, eliminate non-value added step, decrease HC, increase efficiency, reduce cost, and shorten production throughput time. -Achieve and exceed the volume target within agreed safety, quality and cost standards. Continuously improve the performance and reliability of service of production. -Get sustained improvement for KPI, (eg. OEE, product yield, RFT etc.) through all kinds of methodologies, Eg. Use the approach of Lean, SMED, Kanban, Kaizen, 5S，Skill martrix, etc.-Expand the operations to ensure key strategic launch are achieved.

Shanghai

Manage sterile liquid and sterile powder manufacturing operations.-Manage routine manufacturing activities for sterile products, compliant with GMP regulation and the requirements from SHE. Ensure products delivery on time and with high quality level. -Responsible for deviation handle, material control, staff management, document control, maintenance activity, change control, risk management and all activities related to sterile products manufacturing. Being good at trouble shooting. Familiar with Condor、CAPA、SAP、MES system, etc. -Strength the preventive maintenance, carry out excellent in maintenance and TPM project to reduce shutdown time, increase the equipment availability. Using SMED to reduce change over time. -Annually set target to personnel, follow up the execution status, and conduct yearly performance review. Meanwhile set individual develop plan for improve the ability of personnel.-Participate the whole process of building a new sterile liquid manufacturing line from plant design phase (layout, material flow/personnel flow, PQ, PV etc.) to routine operation, establish relevant manufacturing documents Eg. SOPs, batch records, logbook etc.-Build a new professional sterile liquid production team, passed EMA inspection and start commercial manufacturing which exported to Europe market in 2008.-Manage certain projects. Eg.: Local project like Rocephin 3 shifts manufacturing: build new shifts mode and accomplished all related validation; overcome the barrier from utility stop to the continuous manufacturing, etc. And lead global project -QuaSaR. Perform risk assessment to certain products and entire process by using FMEA methodology, take effective mitigation actions to eliminate/reduce the potential risk. etc. As project manager, being able to use systematical method for project control. Have good communication and negotiate abilities, being good at problems solving.-Using 5s, Lean and 6σmethodology in routine operation management.

Shanghai

Manage the packaging line to produce in-house products and repackaging products(include cool chain product) with high quality level according to the requirements from Roche Guideline and GMP regulation. Integrate all kinds of resources necessary to ensure the smooth process in packaging area.- Personnel management: staff enrollment, dismiss, training,performance management etc.- Document management: Establish, maintain, training for SOPs, batch records, logbook as well as other documents related to the production. -Routine production management: Confirm production plan and set personnel arrangement, discrepancy handling, labor force and cost control, change control, material control, etc.- Perform process optimization and continuously improvement to improve the product quality and efficiency.-Manage certain projects. Such as upgrade new semiautomatic packaging line.

Shanghai

-Organize process validation and cleaning validation. Establish the validation plan, training the relevant operator, ensure the validation successfully executed, finished the report finally. -Establish SOPs, batch records as well as other documents related to the production. -Apply technical support when deviation happened during manufacturing process. -Organize internal GMP compliance inspection. -Give technical support for registration, prepare dossier and submit to SFDA .- Packaging material standard control and management.-As the secretary of general branch of the Communist Youth League, organized all kinds of activity such as: family medicine-chest, career design and navigation, etc.