At a Glance
- Tasks: Test and release innovative nanocell-based therapeutics in a hands-on lab environment.
- Company: Join EnGeneIC, a pioneering biotech company focused on cancer treatment.
- Benefits: Gain valuable experience in a dynamic field with opportunities for growth.
- Other info: Be part of a collaborative team driving innovation in clinical-stage biotechnology.
- Why this job: Make a real difference in patient care while developing your QC expertise.
- Qualifications: Tertiary degree in relevant science fields and some lab experience preferred.
The predicted salary is between 45000 - 55000 $ per year.
En Gene IC 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
En Gene IC is a clinical-stage biotechnology company developing targeted nanocell therapeutics for cancer treatment.
With a focus on innovation and precision medicine, En Gene IC 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.
Quality Control Analyst in Ryde employer: EnGeneIC Pty Ltd
EnGeneIC Pty Ltd offers a dynamic work environment where employees can develop their expertise in quality control within the field of nanocell-based therapeutics. The company emphasizes hands-on roles that contribute directly to patient safety and product quality, providing opportunities for professional growth and collaboration within a multidisciplinary team. Employees benefit from engaging in meaningful work that supports innovative therapeutic solutions.
