Description:
As QC In-Process Scientist, you’ll be joining an organisation 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 In-Process Team Lead.
Your Responsibilities
- This role will involve shift work.
- 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.
- Other related duties assigned by management.
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.
- 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 In-Process 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.
Knowledge
- Knowledgeable of regulatory bodies, FDA/EMA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines is a plus.
- General knowledge of Biologics Drug Substance.
Qualifications
- University degree in related science/quality discipline required.