Senior Manufacturing Specialist (Pharma/Biotech)

Responsibilities:

• Monitor, optimize, and troubleshoot issues related to either fermentation/cell culture or protein purification processes and unit operations.
• Supervise the 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, change records, etc.
• 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.
• 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.
• Collaborate with multidisciplinary teams to achieve project objectives.

About You:

• Has 1 to 2 years supervisory experience in the Biologics (Upstream/Downstream/Central Services).
• Bachelor's degree in a relevant life science field (e.g., biology, biotechnology, biochemistry).
• 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/convert subject to performance review.

Based in Tuas.