EnGeneIC is a clinical-stage biotechnology company developing targeted nanocell therapeutics for cancer treatment. With a focus on innovation and precision medicine, EnGeneIC is expanding its production capabilities to support clinical and commercial manufacturing of its proprietary therapeutics.
Role Overview
EnGeneIC is seeking a Biomanufacturing Engineer or Biomedical Manufacturing Scientist to join its high-performing production team. This is a senior technical role—ideal for someone with GMP manufacturing experience who is capable of hands-on work and cross-functional collaboration. The successful candidate will play a key role in translating protocols into cGMP-compliant processes, supporting CDMO interactions, and contributing to the production of nanocell-based cancer therapeutics.
Core Responsibilities
- Participate in the manufacturing of EnGeneIC’s targeted nanocell therapeutics.
- Support CDMO tech transfer and process translation for cGMP production.
- Contribute to R&D; and process development initiatives.
- Draft and maintain batch records, SOPs, and GMP documentation.
- Ensure compliance with TGA, FDA, and EU GMP standards.
- Perform QA checks on raw materials and support inventory control.
- Collaborate with QA, QC, and R&D; teams to ensure manufacturing readiness.
Technical Profile
- Strong working knowledge of sterile manufacturing, cleanroom operations, and GMP documentation.
- Experience with fermentation,
x-flow filtration and lyophilisation procedures.
- Familiarity with applied microbiology and contamination control.
- Proven ability to write SOPs and work instructions for sterile processes.
- Experience preparing documentation for GMP-regulated environments.
Candidate Attributes
- Self-motivated and dependable; thrives in a team-based, hands-on workplace.
- Quick learner with a results-driven mindset and attention to detail.
- Excellent communication, documentation, and time management skills.
- Comfortable working independently and collaboratively across departments.
Qualifications
- Tertiary degree in Biological Engineering, Biotechnology, or related Life Sciences field.
- 5+ years of experience in biomanufacturing or GMP production preferred.
- Early-career candidates with strong technical aptitude and relevant experience will be considered.
Your application will include the following questions:
- Which of the following statements best describes your right to work in Australia?
- How many years' experience do you have as a biomedical engineer?
- Have you completed a qualification in biomedical engineering?
- Have you worked in a role which requires a sound understanding of Good Manufacturing Practices (GMP)?
- Do you hold Australian Security Clearance?
- Do you have a current Police Check (National Police Certificate) for employment?
Pay: $85,000.00 – $95,000.00 per year
Work Location: In person
📌 Biomanufacturing Engineer / Biomedical Manufacturing Scientist (North Ryde)
🏢 EnGeneIC
📍 North Ryde
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