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 environment.
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 solid technical aptitude and relevant experience will be considered.