南京招聘

e successful applicant for this position will be joining the Cell Banking group reporting to the Head of Development Services within Lonza Biologics, Guangzhou, China. The Cell banking group are responsible for the creation and maintenance of the cGMP master and working cell banks used for the production of novel therapeutic recombinant proteins for Lonza’s global client base. The purpose of this role is to lead and manage the cell banking team to execute and successfully deliver projects to meet the business goals. This role is also expected to provide technical expertise for the cell banking activities to ensure they are executed with a high standard in compliance with ICH guidelines, GMP and business principles

The role holder will eventually lead a team of 4 to 5 FTE and have a demonstrated track record and genuine interest in developing high performing individuals and teams.

Owner of quality records (batch record, SOP, Deviations, CAPAs, change controls, tasks, effectiveness checks).

Author and perform technical review of study data, protocols and reports to ensure delivery of high quality and GMP compliant results.

Document approval for all cell banking related documents including but not limited to batch records, SOP, deviations.

Reviews cell banking sections of regulatory submissions in order to ensure accuracy and compliance.

Subject matter expert representing for all cell banking projects in customer audits, quality audits (internal and external) and regulatory audit

Documentation of results in accordance with Lonza policies and current Good Manufacturing Practices (cGMP)

Responsible for ensuring all batch review activities on all cell bank records are completed and available for cell bank release review on agreed schedule.

Craft, align and execute the manufacturing functional strategy to deliver strategic business objectives in the cell banking area.

Manage and deploy of resources (people/skill sets/equipment) to maintain agreed production schedules, control bottleneck process performance and resolve operational constraints to improve productivity.

Maintain effective end-to-end process control mechanisms and performance metrics to deliver breakthrough performance in process control, safety, GMP compliance, quality, cost and service

Take a lead role in adherence to safety rules and regulations and proactively suggesting and leading areas of improvement

To perform hands-on laboratory work as necessary to support cell banking activities.

Activities include cell culture work (subculture, aseptic techniques), training, supervisor sign off of documentation, audits and off plant office based activities (document and report writing/review, leading quality meetings, writing quality documents, audit responses and leading investigations and improvements).

Reviewing draft reports, proposals, presentations and scientific data to maintain the highest level of quality standards within the group

Contributing to customer projects by generating, interpreting and/or reviewing scientific data from work performed by team or oneself, highlighting any atypical or unusual results and leading the investigation.

Engage with customers as the face of the cell banking functional team to align customer needs with operational execution.

Maintain sufficient technical / regulatory / business knowledge to represent the cell banking group internally on Customer project teams and externally at Customer visits, sales processes or any other associated activities

关于龙沙
在龙沙，我们将技术创新与卓越生产及工艺完美结合，助力我们的客户在保健、防腐与保护领域实现他们的研发成果。

我们是全球制药、生物技术与特殊成分市场的优秀合作伙伴。 我们致力于疾病预防，并通过助力客户推出创新药物用以辅助治疗或治愈一系列的疾病，促进我们的世界更健康。同时，我们也提供广泛的微生物控制解决方案，共同营造和维护健康的环境。

1897年，龙沙诞生于瑞士的阿尔卑斯山脉地区，迄今拥有 120 个生产基地和办事处，遍布全球超过35个国家。 我们拥有约15,500名全职员工，由他们组成的高效团队及每一名员工都为我们的业务和所在地区及国家做出意义非凡的改变。2019 年，公司销售额达59亿瑞士法郎，核心业务的息税折旧摊销前利润（EBITDA）达16亿瑞士法郎。更多详情，请访问 *************。


About Lonza
At Lonza, we combine technological innovation with world class manufacturing and process excellence. Together, these enable our customers to deliver their discoveries in the healthcare, preservation, and protection sectors.
We are a preferred global partner to the pharmaceutical, biotech and specialty ingredients markets. We work to prevent illness and promote a healthier world by enabling our customers to deliver innovative medicines that help treat or even cure a wide range of diseases. We also offer a broad range of microbial control solutions, which help to create and maintain a healthy environment.
Founded in 1897 in the Swiss Alps, Lonza today operates in 120 sites and offices in more than 35 countries. With approximately 15,500 full-time employees, we are built from high-performing teams and of individual employees who make a meaningful difference to our own business, as well as the communities in which we operate. The company generated sales of CHF 5.9 billion in 2019 with a CORE EBITDA of CHF 1.6 billion. Find out more at ************* and follow us on Twitter @LonzaGroup or Facebook @LonzaGroupAG.