Biotechnologist (2027 Intake, Entry Level)

WuXi Biologics; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

WuXi Biologics in Singapore's Tuas Biomedical Park seeks a Biotechnologist to execute day-to-day Drug Substance manufacturing within GMP-compliant operations. The role includes documentation, qualification, and involvement in facility start-up activities to enable a successful manufacturing launch.

You will collaborate with Quality, Engineering, Validation, and Supply Chain, participate in process transfers, and manage samples, calibration, and training to ensure production schedules are met.

Qualifications

• Bachelor’s degree required in a related field (Pharmaceutical/Chemical/Biochemical Engineering, Biotechnology, Biochemistry)
• Experience in biopharmaceutical manufacturing or cleanroom environment preferred
• Fresh graduates welcome to apply
• Overseas training opportunities available

Responsibilities

• Perform GMP-compliant manufacturing operations including aseptic processing and media preparation.
• Conduct Environmental Monitoring (EM) during recovery operations as directed by QC.
• Prepare, review and revise GMP documentation (SOPs, MBRs, URS, FAT/SAT).
• Support investigations into deviations, CAPAs, audits, and change controls.
• Coordinate and participate in training activities and maintain training records.
• Support daily manufacturing operations to ensure smooth production schedules.
• Participate in technology transfer projects and provide operational support.
• Manage production samples per established procedures.
• Support equipment lifecycle management including maintenance and calibration.
• Collaborate with Quality, Engineering, Validation, and Supply Chain for continuous improvement.
• Perform additional duties assigned by Supervisor or Management.

Skills

GMP knowledge

Cross-functional collaboration

Time management

Adaptability

Education

Bachelor’s degree in Pharmaceutical Engineering, Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, or related disciplines

Job description

Biotechnologist, Drug Substance Manufacturing Operation

Overview

The Biotechnologist is responsible for executing day-to-day manufacturing operations within the Drug Substance (DS) production area, ensuring activities are performed in compliance with GMP, safety, and quality requirements.

During the project phase, you will support the development, review, and revision of key GMP documentation, including Standard Operating Procedures (SOPs), Master Batch Records (MBRs), User Requirement Specifications (URS), Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and other relevant documents. You will also actively participate in facility start-up activities, including equipment and system commissioning, qualification, validation support, and operational readiness initiatives to ensure a successful project delivery and manufacturing launch.

Working Location : Tuas Biomedical Park. Company shuttle bus is provided across various MRT pick-up locations

Key Responsibilities

• Perform manufacturing operations in compliance with GMP requirements, including equipment and instrument preparation, aseptic processing activities (vial thawing, cell expansion, cell culture, depth filtration, protein chromatography, and filtration), operation and cleaning of disposable and stainless-steel systems, as well as preparation of culture media and buffers. This also includes cleaning, sterilization, and preparation of production parts and consumables.
• Conduct Environmental Monitoring (EM) activities during recovery operations, as authorized by Quality Control (QC).
• Execute cleaning activities within classified cleanroom areas in accordance with GMP requirements, including routine cleaning, changeover cleaning, and equipment cleaning.
• Prepare, review, and revise GMP documentation, including Standard Operating Procedures (SOPs), Master Batch Records (MBRs), User Requirement Specifications (URS), Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), and other relevant documents.
• Support investigation activities related to deviations, change controls, CAPAs, audits, and implementation of corrective and preventive actions.
• Coordinate and participate in training activities, ensuring completion of required training and timely maintenance of individual training records.
• Coordinate and support daily manufacturing operations within the assigned production area to ensure smooth execution of production schedules.
• Participate in technology transfer projects and provide operational support during project implementation.
• Manage production samples, including collection, handling, documentation, storage, and submission in accordance with established procedures.
• Support equipment lifecycle management activities, including routine maintenance, calibration coordination, troubleshooting, and documentation.
• Collaborate with cross-functional teams, including Quality, Engineering, Validation, and Supply Chain, to support operational excellence and continuous improvement initiatives.
• Perform any other duties and responsibilities assigned by the Supervisor or Management.

Requirement :

• Bachelor’s degree in Pharmaceutical Engineer, Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, or related disciplines
• Relevant experience in biopharmaceutical manufacturing or cleanroom environment is preferred
• Fresh graduates are welcome to apply
• Overseas training opportunities is available
• This role may require shift work and support for manufacturing operations in a GMP environment
• Basic knowledge of GMP and regulatory requirements (e.g., 21 CFR Part 11, EU Annex 11)
• Strong coordination and interpersonal skills. Able to work cross-department and work with multi-discipline to drive project to success.
• Ability to work in a fast-paced, dynamic environment
• Self-motivated with good time management and adaptability