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