Bion Environmental Technologies Inc is seeking a Senior Downstream Production Engineer to oversee production scheduling, ensure compliance with relevant regulations, and facilitate inter-departmental collaboration. The ideal candidate should possess a strong background in biotechnology or biopharmaceuticals, especially in the production of protein-based drugs and compliance with GMP standards
Job Summary
The role involves leading downstream production teams to ensure successful completion of manufacturing plans in accordance with GMP standards.
Candidates must possess deep expertise in protein drug scale-up processes and relevant CMC regulatory requirements.
Responsibilities include establishing departmental regulations, writing process and equipment SOPs, and managing technology transfers.
Matching Summary
Match Score: 85
Bion Environmental Technologies Inc is seeking a Senior Downstream Production Engineer to oversee production scheduling, ensure compliance with relevant regulations, and facilitate inter-departmental collaboration. The ideal candidate should possess a strong background in biotechnology or biopharmaceuticals, especially in the production of protein-based drugs and compliance with GMP standards.
Skills & Requirements
Must-have
Protein drug scale-up production experience
GMP and SOP compliance knowledge
Process transfer and validation skills
Equipment operation and maintenance
SOP documentation and writing
Nice-to-have
International audit experience
Cross-departmental collaboration skills
Employee training and technical briefing
Regulatory CMC requirements understanding
Key Requirements
College degree or above in Biotechnology or related field
Proven track record of multi-batch protein production success
Familiarity with domestic and international audit procedures