广东省数字贸易与服务公共服务平台

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

龙沙（中国）投资有限公司成立于2003年9月，是瑞士龙沙集团全资在广州设立的投资性公司。公司旨在于医药、化工及生命科学领域进行投资和再投资，同时提供以下服务：

-协助或代理龙沙所投资企业的货物及设备采购业务，并在国内外市场销售他们的产品；

-为龙沙所投资企业提供售后服务、技术支持及人力资源服务；

-为投资者提供咨询服务并为龙沙的关联公司提供市场信息、投资政策等咨询服务。