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.