Overview:
NUSANTARA PRIME CONSULTING is a Singapore-based company that focuses on technical consulting solutions led by a team of industry practitioners. We have been delivering solutions to clients since 2019 with an impressive portfolio of professional consulting services that are completely customizable for your business.
What You'll Do:
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 processes 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.
Collaborate with multidisciplinary teams to achieve project objectives.
Assist in experimental design and troubleshooting as needed.
Job Requirements:
- 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.
How To Apply:
Interested applicants, kindly email your updated resume/CV to: recruitment@nusaprime.com
We regret that only shortlisted candidates will be notified.
