上海招聘

• To create and maintain cell banks of mammalian cell lines within a cGMP clean room environment.  Activities include cell culture work such as subculture, medium preparation and preparation of end of production cell banks.
• Establish and creating/writing SOPs (especially in the initial phase) for all cell banking related activities
• Perform process transfer (i.e. from development team) and prepare batch records and/or process transfer from customer(s) to accept their cell lines and introduce their media and cell culture process into GMP cell banking facility.
• Trainer for operator qualifications for processing and gowning and other GMP cell banking activities.
• Routine maintenance including but not limited to equipment checks and maintenance, stores, cleaning.
• Management of the GMP cell bank facility such as equipment service, shipping logistics of cell banks, inventory management, equipment replacement and validation.
• Booking and reviewing various internal or external testing such as mycoplasma and adventitious testing and release of cell banks for cGMP manufacturing
• Coordinate and enable shipping schedules/ logistics for sending cell banks for external testing or transfer to other sites/customers
• Document and may own quality records (deviations, change controls, log book checks)
• Accurate completion of batch record documentation, reports and SOPs in accordance with Lonza policies and current Good Manufacturing Practices (cGMP)
• May require to deliver high quality communication to ensure an outstanding customer experience (written reports, presentations, telecons, face to face meetings).
• Working as part of a site and global project team, co-ordinate and lead multiple projects and ensure timely delivery of project workstages.
• Review of data generated by others highlighting any unusual or atypical results/procedures.
• Draft (and start to review) reports generated from cell banking activities at a high level of quality  and scientific standards.
• Mentor and train junior members to assist in their development, providing a transfer of knowledge and hands-on technical training.
• Demonstrated increased understanding of the scientific and technical theory behind Lonza and customer processes.
• Troubleshooting technical challenges in customer projects
• Ownership of cell banking facility areas and/or SOPs
• Start to contribute to technical scoping of proposals.
• The initial phase of this position will be involved in the establishment of the facility (including but not limited to equipment and inventory purchase, equipment and facility validation and qualification runs, facility design and set up).
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• To work to the highest scientific and quality standards under the direction of the Line Manager.
• To communicate project updates to internal and external customers.
• To contribute to the efficient running of the department including instigating and delivering operational efficiency projects.
• Lead improvements in scientific practice and identify error traps within the cGMP facility and within processes to improve standards.
• Contribute to departmental safety and training programmes as required.
• Dependent on scale of project, supervision of project teams may be required.
• The role will require weekend and public holiday working on a rota based system.
• Strong knowledge of cGMP guidelines
• Knowledge and demonstrated application of the relevant ICH guidelines in the area of cell banking.
• Well-organised – must be able to co-ordinate multiple tasks
• Flexible – is willing to undertake a range of tasks for the efficient running of the department.  Is willing to work the hours required for the successful completion of department deliverables

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.