Biotechnologist, Drug Substance (2027 Intake, Entry level)

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

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.

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 :

• Diploma or 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