About the Role

Reporting to the Head of Process Development and Manufacturing, the Bioprocess Engineer will play a key role in developing, optimising, scaling and supporting manufacturing processes for recombinant protein production. The candidate will work across upstream and downstream operations, process characterisation, technology transfer and manufacturing support activities.

Key Responsibilities

- Support development and optimisation of mammalian cell culture processes from laboratory to pilot and manufacturing scale.
- Execute and analyse upstream process development studies including media optimisation, process characterisation and scale-up activities.
- Support downstream purification process development and process improvements.
- Assist with technology transfer of processes into GMP manufacturing environments.
- Prepare technical reports, protocols, batch records and manufacturing documentation.
- Investigate process deviations, implement corrective actions and support continuous improvement initiatives.
- Analyse process performance data and identify opportunities for increased efficiency, productivity and robustness.
- Collaborate with cross-functional teams including R&D;, Quality, Manufacturing and Regulatory Affairs.
- Ensure compliance with GMP, safety and quality requirements.

Skills & Experience

- Bachelor's degree in Biotechnology, Bioprocess Engineering, Chemical Engineering,



Biochemistry or a related discipline.
- Experience in biopharmaceutical, biotechnology or GMP manufacturing environments.
- Hands-on experience with mammalian cell culture and/or recombinant protein production.
- Understanding of upstream and downstream bioprocessing principles.
- Experience with process scale-up, technology transfer or manufacturing support activities will be highly regarded.
- Strong data analysis, problem-solving and troubleshooting skills.
- Excellent written and verbal communication skills.
- Ability to work effectively in a collaborative, multidisciplinary team environment.
- Exposure to GMP manufacturing operations.
- Experience with bioreactor operations and process monitoring systems.
- Knowledge of chromatography and protein purification techniques.
- Familiarity with process validation and regulatory requirements for biologics.
- Experience within a clinical or commercial biopharmaceutical manufacturing setting.

Benefits

- Join an creative Australian biotechnology company with world-class technology.
- Work directly on cutting-edge biologics and therapeutic development programs.
- Opportunity to make a meaningful impact in a growing organisation.
- Collaborative, science-driven culture with strong career development opportunities.
- Competitive remuneration package and employee benefits.

📌 Process Engineer (Sydney)
🏢 i-Pharm Consulting
📍 Sydney