Biotechnologist, Drug Substance Manufacturing

Overview

Drug Substance Biotechnologist is responsible for day-to-day manufacturing operations within the Drug Substance (DS) production area. During the project phase, the role will also support documentation development and plant start-up activities, including equipment commissioning and qualification.

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

Key Responsibilities

• Perform manufacturing operations in accordance with GMP requirements, including:
• Vial thawing, cell expansion, and cell culture
• Depth filtration, protein chromatography, and final filtration
• Operation and cleaning of single-use and stainless-steel systems
• Preparation of culture media and buffers
• Cleaning and sterilization of parts and consumables
• Conduct environmental monitoring (EM) activities during recovery, as authorized by QC
• Perform cleaning activities in cleanroom areas, including periodic, changeover, and equipment cleaning
• Support drafting and revision of GMP documentation (e.g., SOPs, MBRs, URS, FAT, SAT)
• Participate in deviation investigations, change controls, audits, and CAPA implementation
• Support training activities and maintain up-to-date individual training records
• Coordinate daily production activities within the assigned area
• Support technology transfer activities during project phases
• Manage samples and ensure proper handling and documentation
• Support equipment management and routine maintenance activities
• Perform any other duties as assigned by the Supervisor

Requirement :

• Diploma / Bachelor’s degree in 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

Skills & Competencies

• Basic knowledge of GMP and regulatory requirements (e.g., 21 CFR Part 11, EU Annex 11)
• Good communication skills
• Strong teamwork and cross-functional collaboration skills
• Ability to work in a fast-paced, dynamic environment
• Self-motivated with good time management and adaptability