Responsibilities:
- Monitor, optimize, and troubleshoot issues related to either fermentation/cell culture or protein purification processes and unit operations.
- Perform product quality impact assessments and support root cause assessments for process discrepancies and Quality investigations.
- Identify and implement corrective actions, preventative actions and continuous improvements for process and equipment.
- Create, review and revise cGMP documents such as batch records, SOPs, etc.
- Create change records.
- Perform gap and technical assessments for global standards and procedures (GSPs and SOPs).
- Serve as risk lead or subject matter expert in support of risk assessments and hazards analysis e.g. microbial control risk assessments.
- Develop technical training material and conduct technical training for production staff.
- Support the technology transfer of new products/processes e.g. perform field testing.
- Create, review, revise and approve technical reports and engineering documents such as URS, FS, SDS, P&IDs, etc.
- Design, procure, commission, and qualify new equipment.
- Work effectively as part of a team responsible for ensuring successful and efficient processes for the production of recombinant proteins.
- Serve as subject matter expert for regulatory inspections as well as internal audits and support inspection response.
- Serve as RSTO representative in global network teams such as UOTs and task forces.
- Experience in Downstream operations for Drug Substance Manufacturing Operations will be an advantage
- Collaborate with multidisciplinary teams to achieve project objectives.
- Assist in experimental design and troubleshooting as needed.
About You:
- Min. 5 years of experience
- Bachelor's degree in a relevant life science field (e.g., biology, biotechnology, biochemistry).
- Previous experience in a GMP environment is preferred.
- Strong attention to detail, organizational skills, and the ability to work independently or in a team.
- Excellent communication skills, both written and verbal, in English.
- Adherence to safety protocols and regulatory compliance.
Duration: 12 months. Option to extend depending on business needs.
