Biotech Manufacturing Specialist – GMP Drug Substance

Wuxi Biologics Biopharmaceuticals Singapore Private Limited; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Wuxi Biologics Biopharmaceuticals Singapore Private Limited seeks a Biotechnologist to execute day-to-day Drug Substance manufacturing operations in a GMP-compliant environment. You will help develop and revise GMP documents, participate in facility start-up activities, and support deviations investigations with a focus on quality and compliance.

The role includes training coordination, sample management, equipment maintenance, and collaboration with Quality, Engineering, Validation, and Supply

Qualifications

• GMP compliance knowledge.
• Familiarity with environmental monitoring and cleanroom operations.
• Willingness to work in shifts and GMP environment.

Responsibilities

• Execute day-to-day manufacturing operations in DS production area following GMP, safety and quality requirements.
• Support the development and revision of GMP documentation (SOPs, MBRs, URS, FAT, SAT).
• Participate in facility start-up activities, including equipment commissioning and validation support.
• Assist investigations related to deviations, CAPAs, audits, and corrective actions.
• Coordinate training activities and maintain training records.
• Support daily manufacturing operations to ensure production schedules run smoothly.
• Collaborate with Quality, Engineering, Validation, and Supply Chain for continuous improvement.
• Manage production samples and documentation per established procedures.

Education

Bachelor’s degree in Pharmaceutical/ Chemical/ Biochemical Engineering or related

Job description

Wuxi Biologics Biopharmaceuticals Singapore Private Limited seeks a Biotechnologist to execute day-to-day Drug Substance manufacturing operations in a GMP-compliant environment. You will help develop and revise GMP documents, participate in facility start-up activities, and support deviations investigations with a focus on quality and compliance.

The role includes training coordination, sample management, equipment maintenance, and collaboration with Quality, Engineering, Validation, and Supply