上海招聘

职位描述：
1. Lead Tech Transfer and manufacturing coordination for the designated production projects at MFG (Life Science & MDx). Serve as point of contact (POC) in the overall production team discussions between Shanghai and the US. Headquarters.
a) Lead the Tech Transfer activities including gap analysis, manufacturing process discussion, manufacturing document preparation.
b) Understanding the status of tech transfer, production progress and technical challenges/achievement of production projects, and make appropriate presentation to clients and management.
c) Write technical and production reports per requirement of the projects assigned
d) Lead/support for preparation and hosting of regulatory inspection and client/QP audit of MFG for projects assigned
e) Participate in the review/translation of production batch records, deviation, change control, CAPA and regulatory observation response of projects assigned

2. Participate in PD/MFG technology communication and MFG manufacturing summary, more specifically continuous improvement of
a) PD/MFG platform technology alignment
b) Optimization of production execution processes
c) Reduction of deviations/investigations from technology aspect

3. Address regulatory observations/audit findings and CAPA of projects assigned

4. Assist Director of Production, more specifically
a) Host client visit and present overview of Shanghai facility and capability
b) Participate in production process optimization
c) Ensure project production schedules are met
d) Help training in cGMP, technology (ISO9001, ISO13485)
e) Other temporary tasks assigned by Director of Production

5. Strong knowledge of SAP operation for production planning and warehouse management.

6. Basic Qualifications:

a) Oversea degree of Ph.D/MS in a scientific discipline or equivalent is preferred.
b) Minimum 6-8 years working in a cGMP biological manufacturing environment with previous experience managing subordinates and/or leading project teams.
c) Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration.
d) Must be a strong leader able to adapt to daily challenges of manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among subordinates.
e) Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.
f) Experience in working with the cross-functional teams.
g) Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.
h) Must possess good interpersonal skills and the ability to communicate well, both verbally and written. Fluent in both Chinese and English.
i) Good multi-tasking and prioritization skills.

上海普洛麦格(Shanghai Promega)生物产品有限公司是美国普洛麦格公司全资拥有的外商独资企业。公司主要生产和销售细胞生物类、生物化学类、生物试剂盒类、临床诊断试剂盒类产品。公司依托美国普洛麦格总部的研发和技术优势，配备先进的生产设备和训练有素的技术骨干，确保公司的产品在全球市场上具有质量和成本优势，满足公司日益扩大的生产规模之需求。公司的战略目标是成为世界级的蛋白质产品、核酸标记物和分子生物学试剂盒的生产基地。
上海普洛麦格(Shanghai Promega)公司自一九九二年六月成立以来，历年都被认定为高新技术企业和 先进技术企业。公司自一九九七年起全面实行质量体系管理并于二〇〇〇年顺利通过了上海质量体系审核中心的认证，取得了ISO9001的质量体系认证证书，并连续十二年复审通过。二〇一三年又顺利通过了英国BSI ISO 9001:2008和ISO 13485:2003 质量体系认证，取得质量体系认证证书。二〇一四年又获得了上海市食品药品监督管理局颁发的医疗器械生产企业许可证。