CMC Bio/ Process Engineer

SUMMARY:
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POSITION INFO:

Are you passionate about contributing to global health and vaccine innovation? Afrigen Biologics is seeking a qualified and experienced Bio/Process Engineer to join our CMC (chemistry, manufacturing & control) team, creating, implementing and optimizing and processes in the CMC space to support the life cycle of vaccine, adjuvant formulation and therapeutic products. The appointee will be involved in internal and external technology transfer and will be adept at handling and processing of data. The candidate should be comfortable working in a diverse, interdisciplinary team and being involved in multiple projects/tasks simultaneously.

Key Responsibilities:

• Assist with building and optimizing data management system supporting CMC function
• Collate and process data from across plasmid, drug substance, drug product manufacturing processes
• Develop and maintain process related documents.

• Assist with writing CMC sections for regulatory filings and reviews for final submissions.
• Assist with writing Technology Transfer documentation.

• Conduct risk assessments and gap analyses.
• Be involved in the scale-up of processes from R & D to production scale of vaccines, adjuvant formulations and biologics in both upstream and downstream manufacturing.
• Contribute to process intensification strategies and implementation
• Establish continuous improvement strategies to eliminate waste and improve safety, quality, and overall operational efficiency.
• Provide troubleshooting support and guidance for technical systems in support of manufacturing, process development, and/or lab operations within a collaborative team.
• Be involved in training scientists, engineers and other staff as required.

Qualifications and Experience:

• Masters degree in Engineering, Chemical or Bioprocess Engineering preferred
• R&D experience in vaccines/biologicals manufacturing
• Able to work independently and effectively within a team/s
• High degree of critical thinking skills and attention to detail
• Experience with cGMP, knowledge of quality and regulatory compliance relevant to Biotech/Pharma industry.
• Excellent organisation and time management skills.
• Excellent written and verbal communication skills, and scientific reporting.
• Proficient in Microsoft Word, Excel, PowerPoint, Outlook and data handling and modelling required.