Assay Development Associate
Summary of Job Description:
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
• 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/Optimise equipment and analytical testing methods.
• Raise change controls and deviations related to QC and assist with non-conformance
• 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