关于职位

基本信息

城市: 无锡

团队: (AMN CN WXSP) Nutricia Pharmaceutical (Wuxi) Co., Ltd. 纽迪希亚制药(无锡)有限公司

工作时间: 全职

职能类别: R&D

资历: 有经验的专业人士

管理经验:

招聘官: Karen WANG | Karen.wang@danone.com

岗位职责和要求

岗位职责:

Responsible for FSMP new product process development, factory transfer and related technical dossier development for new product registration. Ensure pilot lab safety and good documentation of all trials to meet GB related requirements. Responsible for pilot lab daily management. Report to China R&I director based in WUXI Supply Point.

Main responsibilities:

·         Manage a team of process development and pilot lab engineers. Responsible for daily management of process development and pilot lab staffs tasks.

·         Responsible for coordinating and communicating with internal departments;

·         Responsible for new products process development, and factory transfer, meeting all transfer related requirements.

·         Actively work with NPD, FSMP workshop and Supply Point cross functional team to conduct factory transfer. Ensure factory transfer meeting agreed timeline.

·         Responsible for related process study and transfer validation report and technical dossier writing. Prepare related documents for registration according to GB and regulatory requirements. Ensure the success of trial production by working closely with workshop leader and QC/QA. Ensure the regulatory compliance and successfully passing SAMR onsite inspections to secure new products approval.

·         Responsible for shelf life study sample handling. Closely monitoring shelf life testing timing, ensure shelf life sample are hand over to QC on time for each time point testing per shelf life study requirement.

·         Ensure pilot lab SOPs are up to date meeting quality and GB standards. 

·         Network closely with global process development team and global other supply point process technology experts for best practice.

·         Responsible for all pilot lab equipment purchase, maintenance and repair. Ensure all pilot line equipment are in good condition and calibration are done to meet internal and GB standards.

·         Responsible for pilot lab management and budgeting, pilot raw material management.

·         High quality, efficient, flowless execution of the products process development and transfer by closely working with cross functional team.

·         Responsible for department safety. Contribute and support company audits in safety, environment, health and quality.

·         Explore new process technology for new product innovation.

·         Ensure process development and transfer official documents are agreed and executed in FSMP workshop throughout factory transfer.

·         Provide technology training and supervision to process develop engineers and pilot lab engineers.

·         Take other duties assigned by N+1 R&I director.

岗位要求:

·         MSc in food technology, chemical engineering, chemistry and pharmaceutics

·         10+ years in iFSMP or aFSMP or IMF or pharmaceutical process development and factory transfer experiences

·         Work experience as manager, team leader or project manager, good prioritization skill and ability to work on multiple projects.

·         Indepth knowledge of China iFSMP and aFSMP and related regulation and GB requirements

·         Experience in strategic planning, development, implementation, execution

·         Good team working, communication, negotiation, project management and coordination skills                            

·         Be aware of competitors products technology trends, and conduct competitor analysis. Improve new products process development and problem solving.

·         Actively involved in global R&D network to gain technology expertise via technical training and best practice sharing.

·         Establish and maintain network of contacts with suppliers and research institutes.

·         Manage and develop team to ensure process technology competencies are up to global R&I standard. Keep regrettable talent loss to equal or below comparing to China industry norm.