Senior Biotechnologist Upstream Process

Wuxi Biologics Biopharmaceuticals Singapore Private Limited; Singapore; On-site; SGD 45,000 - 65,000; Full time

Job summary

A leading biopharmaceutical company in Singapore is seeking candidates for overseeing upstream processes, including cell culture and GMP compliance. The ideal candidate should have a Diploma or Bachelor's degree in relevant fields and 2-4 years of experience in cleanroom environments. Familiarity with MES/PCS systems is advantageous. Responsibilities include managing instrument operations, documentation preparation, and ensuring compliance with GMP standards in a dynamic setting.

Benefits

Overseas training program

Company transport provided islandwide

Qualifications

• Minimum 2 - 4 years of relevant experience in a manufacturing or cleanroom environment preferred.
• Good understanding of GMP standards and regulatory requirements.
• Proactive and adaptable to fast-paced environments.

Responsibilities

• Oversee instrument preparation and execute upstream processes.
• Conduct environmental monitoring and ensure cleaning activities meet GMP standards.
• Prepare and revise documentation such as SOPs, MBRs, and other related records.
• Manage daily upstream operations and coordinate cell bank management activities.

Skills

Coordination skills

Interpersonal skills

Knowledge of GMP standards

Familiarity with MES and PCS systems

Team-oriented

Education

Diploma / Bachelor’s degree in Chemical/Biochemical Engineering, General Engineering, Biochemistry, or Electrical & Instrumentation

Tools

MES systems

PCS systems (DeltaV, Unicorn)

Job description

Job Responsibilities

• Oversee instrument preparation and execute upstream processes including cell expansion, cell culture, depth filtration, and other operations in compliance with GMP requirements.
• Perform aseptic techniques such as vial thawing.
• Conduct environmental monitoring during recovery as authorized by QC.
• Ensure cleaning activities within clean areas meet GMP standards, including periodic, changeover, and equipment cleaning.
• Prepare and revise documentation such as SOPs, MBRs, URS, FAT, SAT, and other related records.
• Participate in investigations, implement changes and deviations, and support audit and corrective actions.
• Coordinate and deliver training sessions, maintain personal training records in a timely manner.
• Manage daily upstream operations and ensure smooth coordination.
• Oversee cell bank management activities.
• Contribute to technology transfer projects.
• Handle sample management tasks.
• Manage equipment operations, maintenance, and related activities.
• Perform any additional responsibilities assigned by the direct supervisor.

Requirements

• Working Location : Tuas Biomedical Park with company transport provided islandwide
• Overseas training program is available
• Diploma / Bachelor’s degree in Chemical/Biochemical Engineering, General Engineering, Biochemistry, or Electrical & Instrumentation.
• Minimum 2 - 4 years of relevant experience in a manufacturing or cleanroom environment preferred;
• Familiarity with MES and PCS systems (e.g., DeltaV, Unicorn) is an advantage.
• Strong coordination and interpersonal skills; able to collaborate across departments and disciplines.
• Good understanding of GMP standards and regulatory requirements (e.g., 21 CFR Part 11, EU Annex 11).
• Team-oriented, proactive, and adaptable to fast-paced environments.