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
