Company description:
Wu Xi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries.
Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.
The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies.
QC In-Process Scientist As QC In-Process Scientist, you will be part of a shift team in QC working on various technical projects/activities in Wu Xi Biologics.
The site is focused on start-up activities involving commissioning and qualification aligned with project timelines.
As part of the project, the role will evolve based on project timelines, and may require candidates to carry out additional job functions not described in the job description but associated with the role.
Organization Description Wu Xi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries.
Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals and we provide our clients with a world-leading open access technology platform.
Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide.
We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.
Department Description As QC In-Process Scientist, youll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.
Participate in QC In-Process testing GMP Lab set up, including lab design, construction, and commissioning of the new facility for production of biologics drug substance.
Perform analytical method transfer, verification/validation and routine analysis using various analytical techniques; including but not limited to HPLC - Reverse Phase and Affinity Chromatography, UV Spectrophotometer UV-Vis and Solo VPE.
Working alongside manufacturing shift pattern to support forward processing in-process activities, receipt, and testing of batch samples for protein estimation and concentration.
Drive the establishment of required inventory for In-Process team and develop a system for stock control of laboratory consumables and reagents.
Participate in Lab risk assessment, including Quality risk assessment and EHS risk assessment, ensuring tasks are performed in a safe manner.
Participate and Lead various Lab deviation and investigation process such as OOS, OOT and non-conformance, including the implementation of CAPAs and change control.
General laboratory support such as leading and maintaining a process for housekeeping, inventory, Consistently delivering and monitoring specific Lab Key Performance Indicators.
Your Profile The ideal candidate for this position, will have the following: Technical Competencies Experience and knowledge of general Quality Control Biologics function and activities.
Knowledge Knowledgeable of regulatory bodies, FDA/EMA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines is a plus.
Excellent interpersonal, verbal, and written communication skills Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities.
As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.
Reach beyond yourself and discover your true potential If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential.
Apply now Would you like to know more before you apply? Please visit us ator contact us via Wu Xi Biologics is an equal opportunities employer.