Manufacturing Supervisor, Drug Substance Downstream 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 stateoftheart CDRMO operations. This role offers a unique opportunity to be involved from facility startup through commercial manufacturing, working with advanced downstream processing technologies in a fastpaced and collaborative environment

Location : Tuas Biomedical Park (Company transport provided islandwide)

Key Responsibilities

• Oversee the preparation and use of equipment and materials, including protein chromatography, filtration, packing, and transportation activities in compliance with GMP requirements.
• Supervise cleaning activities within cleanroom areas, including periodic cleaning, changeover cleaning, and equipment cleaning in accordance with GMP standards.
• Lead the drafting, review, and revision of controlled documents such as SOPs, MBRs, URSs, FATs, SATs, and other GMP documentation.
• Oversee and participate in investigations related to deviations, changes, audits, and corrective actions, ensuring timely implementation and closure.
• Provide timely feedback to management on process performance, personnel matters, safety concerns, production environment issues, and equipment or maintenance-related matters.
• Coordinate and oversee staff training activities, ensuring training plans are executed and individual training records are maintained accurately and on time.
• Communicate and coordinate with Engineering and other relevant departments on equipment maintenance, calibration, and performance verification.
• Oversee environmental monitoring (EM) activities during bulk filling operations, as authorized by Quality Control.
• Support and coordinate other GMP-related activities within the department, including logbook reviews, batch production record (BPR) reviews, and the cleaning and sterilization of parts and consumables.
• Manage daily upstream operation coordination to ensure smooth and compliant manufacturing activities.
• Oversee cell bank management activities in accordance with GMP requirements.
• Lead and participate in project-related technology transfer activities.
• Oversee sample management activities, including collection, storage, and documentation.
• Manage equipment lifecycle activities, including usage tracking, maintenance coordination, and documentation.
• Drive team building and personnel development, ensuring appropriate staffing levels and fostering a positive, collaborative team culture.
• Handle routine group and departmental administrative activities.
• Perform additional duties as assigned by the direct supervisor.

Requirement:

• Diploma / 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