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Biotechnologist, Drug Substance Manufacturing - job post

WUXI BIOLOGICS BIOPHARMACEUTICALS SINGAPORE PRIVATE LIMITED
Singapore
$4,000 - $5,000 a month - Permanent, Full-time
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Job details

Pay

  • $4,000 - $5,000 a month

Job type

  • Permanent
  • Full-time

Shift and schedule

  • Shift system

Location

Singapore

Full job description

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
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