The Scientist will be part various technical projects/activities in the QC Microbiology Group of WuXi Biologics. The site is focused on startup activities involving commissioning and qualification work with aggressive timelines and potential candidates are required to be flexible in this regard.
Essential Duties and Responsibilities
Specific Start up activities:
- Ensure the tasks associated with the startup and routine operations of a QC microbiology laboratory are carried out in a safe manner.
- Support QC Microbiology lab set-up, including laboratory design and construction queries, equipment installation and qualification utilizing principles of Operational Excellence and Lean Labs.
- Microbial organism identification, supporting facility qualification, cleaning validation, process validation, etc.
- Develop and maintain quality systems within the QC Microbiology Laboratory to ensure compliance to cGLP.
- Support of the commissioning/qualification activities of utility systems including but not limited to Water systems, Clean Steam and process gases, including development of sampling strategies.
- Aiding in the identification and development of Contract Test laboratories and strategies.
- Development of training material for the QC Microbiology Laboratory personnel.
- Support microbial method validation and development of routine testing strategies.
- Perform QC microbiology routine testing, environmental monitoring, water monitoring, and testing including, sterility, endotoxin, bioburden, Biological Indicators, Growth promotion and routine microbial identification strategies.
- Routine monitoring of laboratory KPI’s, stock control of laboratory consumables and reagents and support for future expansion/upgrade projects.
- Support QC Senior scientist in OOS, OOL, microbial contamination, adverse trends, utility and environmental excursion investigations, change controls, and CAPAs tasks.
- Author technical documents including methods protocols, qualification/ validation protocols and reports, SOPs, etc.
- Support Risk Assessments for projects and business innovation initiatives from a microbiological perspective.
- Defines specific aseptic techniques to be performed for crucial process steps and provides meaningful input to processing operations as site develops.
- Keep abreast of current corporate and regulatory trends and requirements pertaining to laboratory operations and aseptic manufacturing.
- Ability to handle regulatory inspections from FDA, EMA, etc. and cGMP audits from clients, as well as internal audits.
- Participate in relevant internal and external QC related audits.
- Ability to work in a team environment and independently as required
- Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Biologics Policies and Standard Operating Procedures.
- Thorough understanding of current Good Manufacturing Practices
- Other duties as assigned