Reporting to the QC Separation Lead- Associate Director/Senior Scientist, the QC Separation Associate Scientist will be part of various technical projects/activities in the QC Separation 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.
Essential Duties and Responsibilities
- Participate in QC Separation 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.