南京招聘

Responsibilities

    

Responsible for the manufacture of therapeutic proteins under cGMP conditions. This individual is highly competent in the relevant technical knowledge, operating systems and equipment expertise in the respective function. In addition, this individual is recognized as the subject matter expert for most of the process unit of operation and is designated as the point of contact for process and equipment troubleshooting.

    

This position reports to the Senior/ Section Lead/ Manager of the Large or Small Scale Manufacturing Team.

    

    

Detailed responsibilities:

    

· Display superior process understanding & equipment troubleshooting ability under both routine & non-routine scenarios

    

· Maintain currency of knowledge in emerging and advances of technologies

    

· Attain subject matter expertise in ≥ 2 areas of manufacturing operations e.g. USP: Media

    

Preparation & Primary Recovery, DSP: Column Packing & Bottling, SUP: Buffer Preparation

    

& Dispensing,

    

· Attain 100% trainer qualifications in identified areas of specialization

    

· Able to assimilate quickly to leadership roles in other process areas outside of areas of specialization

    

· Participate in Customer & Regulatory Audits

    

· Follow through to completion Quality Tag-outs, Change Requests, Planned Deviations and/ or Computer Systems Change Controls (CSCCs)

    

· Recognized as a DELTAV system expert and competent in addressing and/ or reviewing

    

Minor/ Major Deviations

    

· Make real-time non-critical decisions on operational issues based on superior knowledge of defined SOPs & policies

    

· Review more critical/ complex decisions with Manufacturing Management and/ or other support functions

    

· Able to identify suite problems, troubleshoot, identify & complete or coordinate corrective action

    

· Provide formal peer review to Snr/ Section Lead and Section Manager

    

· Provide active mentoring/ coaching to Biotechnologists.

    

· Plan and prioritize suite activities/ resource loading on a 2-week look-ahead of production schedule

    

· Excellent coordination skill between departments for multiple parallel activities

    

· Able to communicate manufacturing operations perspective effectively to management.

    

· Highly motivated and is regarded as an upcoming leader both technically and in soft skills

    

· Direct day-to-day manufacturing activities of team as required by Snr/ Section Lead and

    

Section Manager

    

· Able to manage multiple priorities and is recognized by colleagues as a source of expertise

    

· Able to support MSAT, Lot Review and Deviation Investigation groups when situation calls for it

    

· Act as responsible suite designee during technology transfers

    

· Create & present training materials/ seminars on technical/ cGMP issues

    

· Involved routinely in OE improvement projects and make recommendations to improve manufacturing processes

    

· Own & lead process improvements projects (often complex in nature) in collaboration with

    

MSAT/ Engineering

    

· Interview & evaluate the viability of potential new employees in the absence of Snr/ Section

    

Lead and Section Manager

    

· Any other duties as assigned by your Supervisor/ Manager

    

    

Purification (Downstream small/large scale)

    

· Expert skill and knowledge of column chromatography techniques, tangential flow filtration techniques, micro/Nano filtration techniques, pH/Conductivity adjustment techniques, aseptic techniques.

    

· Ability to provide technical knowledge on the chromatography operating interface example using UNICORN software and various DeltaV control parameters for chromatography and

    

UF operation.

    

· Highly proficient in single use applications for the respective processes.

    

    

Education Experience

    

· Preferably with at least 6 years of relevant work experience in a related industry

    

· Degree/Diploma in a related Science/Engineering discipline

    

· Demonstrate commitment to cGMP, EHS compliance aspects of clean-room and production operation

    

· Strong knowledge of Biopharmaceutical processing is an added asset

    

· Excellent Knowledge of cGMP applications

    

· Positive team oriented attitude

    

· Good communication skills

    

· Demonstrate leadership skills

    

· Willing to perform rotating 12-hour shift pattern

    

    

Competencies

    

· Business Acumen

    

· Customer Focus

    

· Driving Results

    

· Leadership

    

· Collaboration

    

· Agility

    

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.