广州招聘

The successful applicant for this position will be joining Analytical Development team within Clinical Development in Lonza Guangzhou, China. The Clinical Development group are responsible for the development and characterization of manufacturing processes 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 analytical development team to execute and successfully deliver projects to meet the business goals.  This role is also expected to provide technical expertise for the analytical development activities to ensure they are executed with a high standard in compliance with International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines, Good Manufacture Practices and business principles

 

Duties and Responsibilities include:

• The role holder will eventually lead a team of 5 to 8 Full Time Employee and have a demonstrated track record and genuine interest in developing high performing individuals and teams.

• At the initial phase, the role holder will lead the team to provide analytical testing to support process development teams as well as conduct Current Good Manufacture Practices analytical activities (analytical method development, validation and product stability testing).

• Responsible for the delivery of activities on multiple parallel commercial analytical development (Investigational New Drug) projects and late stage validation projects (Biologic License Application) locally and cross sites.

• Ensure effective communication within peers, teams and departments locally and in Lonza’s global network.

• Ensure projects are executed and delivered to agreed timelines and budgets with the available resources (people/skill sets/equipment) at high levels of right first time.

• Ensure and participate with the team to deliver high quality communication to provide an outstanding customer experience (written reports, presentations, teleconferences, face-to-face meetings). 

• Collaborate with other departments locally and in Lonza’s global network to ensure consistency in technical approach and procedures

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

• Coach, mentor and train direct and indirect reports in the necessary scientific critique/knowledge and technical skills to achieve the department’s objectives and establish robust succession plans.

• To perform hands-on laboratory work as necessary to support protein structure / function determination. These can include protein characterisation, product stability testing, test method development and assay validation activities.

• Test methods include, but are not limited to, techniques using capillary electrophoresis, high-performance liquid chromatography, oligosaccharide analysis, spectrophotometry, enzyme-linked immunosorbent assay, Quantitative real time polymerase chain reaction, etc.

• Proactively suggest, execute and lead approved operational efficiency projects

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

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

• Take a lead role in day to day department management activities including but not limited to housekeeping, team meetings, equipment maintenance, etc

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

• Owner of quality records at a senior level (Deviations, Corrective And Preventive Actions, change controls, tasks, effectiveness checks).

• Lead and direct study programmes at a senior level including the execution of associated laboratory work once candidate gains sufficient experience in Lonza

• Author and perform technical review of study data, protocols and reports to ensure delivery of high quality and Good Manufacture Practices compliant results.

• Documentation of results in accordance with Lonza policies and current Good Manufacturing Practices – as appropriate.

• 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 qualification runs, facility design and set up).

   

  General:

• To work to the highest scientific and quality standards under the direction of the Head of Department

• Experience in managing people, projects and resources.

• Proven track record operating in a commercial environment enabling teams to achieve against their objectives.

• Able to handle complexity and ambiguity in highly pressured environments.

• Experience working within a formal Quality Management System (such as Current Good Manufacture Practices).

• Able to collaborate effectively with peers and direct reports to achieve goals

• Excellent written and oral communication skills.

• Broad market, technical and regulatory knowledge.

• The role may involve weekend and public holiday work on a rota based system.

• Contribute to departmental safety and training programmes.

• 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

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.

Our vision:

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission:

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.

Do you want to help us as we shape the future of this great organization?

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.