Quality Control Analyst

About the role

EnGeneIC is seeking a Quality Control Analyst to join our laboratory team and support the testing and release of our nanocell-based therapeutics. Working closely with our multidisciplinary team, you will play a critical role in ensuring raw materials, in-process samples, and finished clinical trial material meet the standards required for patient use. This is a hands-on laboratory role with genuine scope to grow your QC expertise.

Key responsibilities

• Test raw materials, in-process samples, and finished clinical trial material against approved specifications and within required timelines.
• Prepare test solutions, reagents, and reference standards as required.
• Perform wet laboratory tests and instrumental analysis.
• Conduct in-process checks and support line clearance during manufacturing.
• Perform and maintain stability trial studies in line with the site's stability testing program.
• Operate, maintain, and calibrate laboratory instruments and equipment.
• Prepare test reports where appropriate and maintain accurate laboratory documentation, including trend records and test methods.
• Initiate and support Out of Specification (OOS) and Out of Trend (OOT) investigations.
• Review and cross-check other analysts' testing as required.
• Maintain general laboratory housekeeping, including reagent/standard inventory, waste disposal, and retention sample management.

About you

• Working knowledge of an analytical laboratory, including wet chemistry and instrumental techniques, with familiarity with pharmacopoeial standards (USP, BP, EP).
• Understanding of GMP/GLP requirements and the regulatory environment for clinical trial material; exposure to biological or microbiological testing is a plus given our nanocell platform.
• Strong attention to detail, particularly in maintaining accurate records and test reports.
• Self-motivated and dependable, comfortable working in a small, hands-on team, with good communication skills across Manufacturing and Quality.
• Adaptable and solution-focused, with a continuous improvement mindset suited to a growing clinical-stage biotech.
• Tertiary degree in Chemistry, Analytical Chemistry, Biochemistry, Science, or a related field.
• Minimum of 2 years experience in a pharmaceutical, biotech, or related GMP-regulated manufacturing environment preferred; strong graduates with relevant laboratory experience will also be considered.
• Applicants must hold valid, unrestricted Australian working rights.

About us

EnGeneIC is a clinical-stage biotechnology company developing targeted nanocell therapeutics for cancer treatment. With a focus on innovation and precision medicine, EnGeneIC is currently progressing through Phase I/IIa clinical trials. As the company grows, we're strengthening our laboratory and testing capabilities to support later-phase trials and future commercial manufacturing.