The Assay Development Associate will be responsible for performing routine sampling and testing following Standard Operating Procedures (SOPs) and established test methods within the function of the GMP Quality Control (QC) and CMC Laboratories. This post will report to CMC Principal Scientist.
- Develop assays for our clinical product testing, including product characterisation, potency, and stability assays
- Perform testing of in-process, final product, stability and raw material samples according to Standard Operating Procedures. Test methods include ELISA, FACS, gel electrophoresis, PCR, spectroscopy, protein assays, potency and identity tests
- Write or revise SOPs for analytics methods
- Assist with establishing procedures for QC sampling and testing
- Write and revise protocols and technical reports as necessary
- Participate in equipment validation, method validations, and special protocols.
- Tracking and trending of generated QC data, as necessary
- Perform sample management including receipt, inventory and aliquoting
- Coordinate shipment of samples to contract testing laboratories and review of testing/data reports
- Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
- Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc.
- Troubleshoot/Optimize equipment and analytical testing methods.
- Raise change controls and deviations related to QC and assist with non-conformance investigations.
- Other duties, as assigned
- Master’s degree in a scientific discipline or other related biological science or Bachelor’s degree with 2 years’ of laboratory experience.
Experience and Skill Requirements:
- 1-3 years of laboratory-based experience in a testing capacity, preferably GMP. Computer literacy (MS Word and Excel), good written and oral communication and organizational skills are required.