We are seeking a proactive, detail-oriented, and agile Biotechnologist to join our expanding Solution Preparation (Media & Buffer Preparation) team at the state-of-the-art Singapore CRDMO Hub in Tuas. This role offers a unique, front-row seat to the operational setup, commissioning, and validation of a world-class biomanufacturing facility from the ground up.
Responsibilities
- Operate and clean disposable and stainless-steel systems; prepare culture media and buffers in compliance with GMP requirements
- Receive, review, and manage production materials in the workshop
- Draft and update SOPs, MBRs, and related documentation
- .Participate in investigations, implement changes and deviations, and support audits and corrective actions
- Coordinate and deliver training; maintain accurate and timely training records
- Collaborate on GMP-related tasks within the department, including logbook and BPR reviews, cleaning, and sterilization of parts and consumables
- Assist with daily administrative activities of the department
- Perform additional responsibilities as assigned by the direct supervisor
Requirement
Qualifications & Experience
- Diploma or Degree in Chemical/Biochemical Engineering, General Engineering, Biochemistry, Electrical & Instrumentation, or a related technical discipline
- 0 to 4 years of relevant experience in the drug substance bioprocess or pharmaceutical industry. Fresh graduates are highly welcome to apply.
- Training Opportunity: Successful candidates will be eligible for our Overseas Training Program to accelerate onboarding and technical competency
Technical Competency
- Systems Familiarity: Advantageous to have experience with Manufacturing Execution Systems (MES) and Process Control Systems (PCS), such as DeltaV or Unicorn.
- Regulatory Knowledge: Good foundational understanding of cGMP standards and relevant digital validation regulations (e.g., 21 CFR Part 11, EU Annex 11).
Soft Skills & Attributes
- Collaboration: Strong coordination and interpersonal skills with a proven ability to work cross-functionally across multidisciplinary teams to achieve project milestones.
- Work Style: Team-oriented, proactive, agile, and highly adaptable to dynamic project timelines.