Job Overview: As a QC In Process Scientist, you will be part of a shift team in Quality Control working on various technical projects/activities. You will be responsible for participating in the setup of GMP labs, including lab design, construction, and commissioning. Additionally, you will perform analytical method transfer, verification/validation, and routine analysis using various techniques such as HPLC - Reverse Phase and Affinity Chromatography.
Key Responsibilities:
* 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 SoloVPE
* Working alongside manufacturing shift pattern to support forward processing in-process activities, receipt, and testing of batch samples for protein estimation and concentration
* Support out of hours QC activities (E.g. sample management, alarm management, FTIR, density analysis)
* Perform data review of analysis, troubleshooting, technical support, and shift lead
* Participate and Lead activities including general lab readiness, audit readiness, housekeeping, laboratory equipment qualification, routine calibration, and maintenance
* Prepare and review required GMP documents such as SOPs, protocols, methods, and reports
* Drive the establishment of required inventory for In-Process 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, ensuring tasks are performed in a safe manner
* Maintaining high Quality, Compliance and Safety system in a Drug Substance GMP Laboratory
* Participate and Lead various Lab deviation and investigation process such as OOS, OOT and non-conformance, including the implementation of CAPAs and change control
* Develop training process for QC In-Process testing team, train and coach Associate Scientists and other QC personnel
* General laboratory support such as leading and maintaining a process for housekeeping, inventory, Consistently delivering and monitoring specific Lab Key Performance Indicators
Requirements:
* Technical Competencies Experience and knowledge of general Quality Control Biologics function and activities.
* Possess knowledge of routine and non-routine QC/in process testing.
* Experience with regulatory/customer audits is desirable.
* Experience Previous experience from QC Pharmaceutical/Biopharmaceutical using Chemistry analytical techniques; Liquid Chromatography and Spectroscopy is required.
* Experience with training and coaching of personnel.
* Experience working in a Biologics QC Chemistry or InProcess testing Lab involving method transfer and validation is strongly desirable.
* Previous experience with start-up Biologics Laboratory is desirable.
* Previous experience working in a Quality Control Laboratory at a senior level is desirable.
* Experience with systems such as Empower CDS, Trackwise and LIMs or related system is required.
* Experience with Microsoft Word, Excel, and PowerPoint is required.
Benefits:
* Bonus
* Canteen
* Life Assurance
* Paid Holidays
* Parking
* Pension
* VHI
What We Offer: WuXi Biologics is an equal opportunities employer. We provide a dynamic and fast-paced work environment where our employees can thrive and grow professionally.