Biomanufacturing Technical Officer

2 days ago

North Ryde, Australia EnGeneIC Pty Ltd Full time

We have a unique manufacturing process, and we are currently seeking a Manufacturing Technical Officer for our Production facility to join our highly dedicated production team.

**Skills, Knowledge, and Experience**:

- Minimum 5-year GMP experience working in a sterile pharmaceutical manufacturing/production environment (Grade A / CL3), including experience with sterile gowning procedures.
- Minimum 5-year experience in translation and development of lab scale processes to large scale commercial manufacturing.
- Minimum 5-year experience working with small scale and large-scale Tangential Flow Filtration (TFF) Systems including handling single-use large-scale sterile manifolds and liquid filtration systems.
- Minimum 5-year experience working with small and large
- scale single-use fermentation systems including cell culture flasks, bottles, bioreactors and bacterial purification techniques.
- Experienced in the safe handling practices for viruses and GMO’s.
- Minimum 5-year experience managing Quality Management System items including Deviation Reports, CAPA’s, Risk Assessments, Change Controls.
- Possess a full understanding of the importance of quality assurance and product integrity as well as document traceability with ability to generate and review SOP’s, batch records and other cGMP related documents.
- Have previous experience navigating FDA/TGA audits and have awareness of their respective current policies and legislation.
- Able to understand detailed instructions and work procedures with previous experience in formulating liquid and powder batches from manufacturing instructions.
- As part of a small team participate in equipment preparation, packaging, cleaning and steam sterilisation of consumables and facility cleaning (weekly).

**Personal Attributes**:

- Possess sound interpersonal and English communication skills (spoken and written).
- Attention to detail and strong commitment to quality.
- Self-motivated and proactive approach to daily operations.
- Demonstrated ability to work effectively in a team and in a changing environment

**Desirable but not essential skills include**:

- Experience with cancer treatment biotechnology desirable.

**Joining us**:
If you feel that you are ready for a new challenge and at the same time work with a cutting edge biotechnology to really make a difference for cancer patients, please forward your CV with a cover letter including the names of two referees to:
Pay: $80,000.00 - $95,000.00 per year

Schedule:

- Monday to Friday

**Experience**:

- Biotechnology Manufacturing: 5 years (required)

**Language**:

- Professional English (required)

Work Location: In person

Application Deadline: 21/10/2024

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