上海招聘

Essential Functions of the job:

· Provide guidance and direction regarding Quality Control and Assurance to project teams & CMO

· Lead and implement the batch record review including QC & MFG and support batch release work

· Support and implement the on-site quality control work in CMO per quality agreement and GMP

· Drive, lead and troubleshoot quality investigations /changes at CMOs to ensure that all critical and major quality control issues are thoroughly investigated with appropriate corrective actions

· Support annual product reviews and the development of training programs regarding all aspects of producing quality products

· Monitor performance metrics and drive continuous improvements of CMO QC work

· Assess and revise, as needed, SOPs for GMP Quality functions and identify opportunities to streamline systems and processes

· Provide audit/inspection support of CMO, perform audits & support to regulation filling, as needed Core

Competencies, Knowledge and Skill Requirements

In-depth knowledge of Ch.P (NMPA), other regions including USP, EP and JP is preferred

Familiar with lab operation including instrument, method, documentation, stability work in dteail

In-depth knowledge of GMPs (NMPA), other regions including US, EU, AU and JP is preferred

In-depth knowledge of Quality principles, concepts, industry practices and standards

Excellent verbal, written and interpersonal communication skills

Ability to work independently with business/scientific/technical personnel is preferred

Knowledge of risk management tools a plus

Communication & Interpersonal Skills

. Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail Significant Contacts

· Interacts with all levels of BeiGene & CMO employees

· Interacts with members of China /SH NMPA REQUIREMENTS Experience

· Minimum of 10 years pharmaceutical or biotechnology industry GMP experience in a quality control in manufacturing function

· Familiar with lab instruments including HPLC, GC, UV, IPC, ElISA, CZE etc

· Familiar with quality control work requirement of sterile product ( injectable solution)

百济神州是一家植根中国的全球性商业化生物医药公司，致力于成为分子靶向药物和免疫肿瘤药物研发，及商业创新领域的全球领导者。
2017年，百济神州与新基公司达成战略合作伙伴关系，向新基转让了tislelizumab在美国、欧洲、日本和亚洲以外的其他地区的实体瘤开发和商业化的独家权益，保留了在亚洲（除日本外）开发和商业化tislelizumab用于治疗实体瘤的权益，以及用于治疗恶性血液肿瘤和进行内部组合疗法的全球范围权益。

此外，百济神州获得了新基公司在华获批药物——注射用白蛋白紫杉醇（ABRAXANE？）, 瑞复美（REVLIMID？）和 维达莎（VIDAZA？）的独家授权，并接管其在华商业运营团队。

2018年1月，百济与Mirati公司sitravatinib在亚太地区的独家授权协议，进一步拓宽了公司的产品组合。

截至目前，百济神州在全球各地拥有超过1100名员工，其中包括在中国、美国、澳大利亚和瑞士的超过650名科学家及临床医学专家。

公司在中国的北京、上海、美国的马萨诸塞州Cambridge，新泽西州Fort Lee和加利福尼亚州旧金山Emeryville和San Mateo，瑞士的巴塞尔均设有办事机构。除此之外，百济神州在中国大陆还拥有位于北京的研发中心，苏州、广州两大生产基地，以及在上海的商业运营中心。