Supervisor, Drug Substance Upstream Process

As a Team Supervisor, you will play a key role in shaping and operating a new greenfield biologics manufacturing facility at WuXi Biologics Singapore, supporting state‑of‑the‑art CDRMO operations. This role offers a unique opportunity to be involved from facility start‑up through commercial manufacturing, working with advanced downstream processing technologies in a fast‑paced and collaborative environment

Location : Tuas Biomedical Park (Company shuttle bus provided islandwide)

• Oversee instrument readiness, cell expansion, cell culture operations, depth filtration, and other process activities in accordance with GMP requirements. Perform aseptic procedures such as vial thawing.
• Supervise environmental monitoring (EM) during recovery activities as authorized by QC.
• Ensure proper cleaning of cleanroom areas in line with GMP standards, including periodic cleaning, changeover cleaning, and equipment cleaning.
• Lead the drafting, revision, and maintenance of SOPs, MBRs, URS, FAT/SAT documentation, and other controlled documents.
• Oversee and participate in investigations, change control, deviation management, and audit/inspection follow-up actions.
• Escalate issues related to process performance, personnel, safety, production environment, and equipment maintenance to leadership promptly.
• Oversee staff training or coordinate required training activities, ensuring timely completion and accurate maintenance of training records.
• Communicate with Engineering and other relevant departments to coordinate equipment maintenance, calibration, and facility support needs.
• Support GMP activities within the department, including logbook review, BPR review, cleaning and sterilization of parts and consumables, and other assigned duties.
• Lead or contribute to drafting and updating SOPs, MBRs, and related documentation.
• Provide oversight for daily upstream operations.
• Oversee cell bank management activities.
• Participate in and support technology transfer projects.
• Oversee sample handling and sample management tasks.
• Support team development through staff capability building, succession planning, and fostering a positive team environment.
• Oversee equipment management and maintenance processes.
• Manage routine administrative tasks for the team and support departmental administrative needs.
• Perform any other responsibilities assigned by the direct Supervisor.

Requirement :

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, General Engineering, Biochemistry, or Electrical & Instrumentation.
• 5 years and above of experience in a manufacturing or cleanroom environment, preferably within a GMP-regulated industry with people management or supervisory experience is an advantage.
• Familiarity with manufacturing and process control systems such as MES and PCS (e.g. DeltaV, Unicorn) is preferred.
• Strong coordination and interpersonal skills, with the ability to work effectively across departments and with multidisciplinary teams.
• Good working knowledge of GMP requirements, including 21 CFR Part 11 and EU Annex 11.
• Positive, team-oriented mindset with strong collaboration skills.
• Self-motivated, adaptable, and able to work efficiently in a fast-paced environment with demanding timelines.
• Overseas Training is required