As a QC Separations Associate Scientist, you will be a part of various technical projects/activities in the QC Separations group of WuXi 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.
Organisation Description
WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.
Department Description
As a QC Separations Associate Scientist, you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you’ll be reporting to the QC Separations Team Lead.
Your Responsibilities: In this role, you will be responsible for the following:
- Participate in QC Separations 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, CE, cIEF and UV
- Support activities including general lab readiness, audit readiness, laboratory equipment qualification, routine calibration and maintenance
- Identify and prepare required GMP documents such as SOPs, protocols, methods and reports
- Drive the establishment of required inventory for Separation team and develop a system for stock control of laboratory consumables and reagents
- Foster Operation Excellence and continuous improvement environment; including implementing Lean tools (5S, Kanban and Kaizen)
- Participate in Lab risk assessment, including Quality risk assessment and EHS risk assessment
- Maintaining high Quality, Compliance and Safety system in a Drug Substance GMP Laboratory
- Participate in 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 housekeeping, and training support
- Consistently delivering and monitoring specific Lab Key Performance Indicators
- Other related duties assigned by management.
Your Profile
The ideal candidate for this position, will have the following:
Education
- University degree in related science/quality discipline required
Knowledge/Experience
- Experience or knowledge of general Quality Control function and activities
- Possess knowledge of routine and non-routine QC/in-process testing
- Experience working in a QC Chemistry Laboratory is desirable
- Experience working in a Quality Control Lab or relevant GMP environment
- Previous experience from Pharmaceutical/Biopharmaceutical using Chemistry analytical techniques; Liquid/Ion Chromatography, Electrophoresis and Spectroscopy
- Experience with Empower and LIMs or related system is required
- Experience with Microsoft Word, Excel, and PowerPoint is required
- Knowledgeable of regulatory bodies, FDA/EMA regulatory requirements applicable to biologics and/or pharmaceuticals.
- Knowledge of ICH and GMP guidelines is a plus.
Personal skills
- Ability to work in a team environment and independently
- Excellent interpersonal, verbal, and written communication skills
- Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities
- Ability to think critically and demonstrate troubleshooting and problem-solving skills.
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!
Would you like to know more before you apply? Please visit us at https://www.wuxibiologics.com/join-us/ or contact us via [email protected]
WuXi Biologics is an equal opportunities employer.
