We are seeking a proactive, detail-oriented, and agile Biotechnologist to join our expanding Upstream Process (USP) team at our 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
- Prepare instruments and perform cell expansion, cell culture, depth filtration, and other process operations in compliance with GMP requirements.
- Conduct aseptic procedures, including vial thawing.
- Perform environmental monitoring during recovery as authorized by QC.
- Execute cleaning activities in clean areas per GMP standards (periodic, changeover, and equipment cleaning).
- Draft and revise documents such as SOPs, MBRs, URS, FAT, and SAT.
- Participate in investigations, change implementations, deviations, audits, and corrective actions.
- Coordinate and deliver training; maintain accurate and timely training records.
- Oversee daily upstream operations and manage cell bank activities.
- Support tech transfer projects and sample management tasks.
- Manage and maintain equipment, ensuring proper functionality.
- Carry out additional responsibilities as assigned by the direct supervisor.
Requirement
- Diploma / Degree in Chemical/Biochemical Engineering, General Engineering, Biochemistry, or Electrical & Instrumentation.
- 0 to 2 years of relevant experience in a bioprocess, pharmaceutical, or cell culture facility. Fresh graduates are highly welcome to apply.
- Training Opportunity: Successful candidates will be eligible for our Overseas Training Program to accelerate technical competency and system onboarding.
- Familiarity with MES and PCS systems (e.g., DeltaV, Unicorn) is an advantage.
- Strong coordination and interpersonal skills; able to work cross-functionally and with multidisciplinary teams to achieve project goals.
- Good understanding of GMP standards and relevant regulations (e.g., 21 CFR Part 11, EU Annex 11).
- Team-oriented, proactive, and adaptable to dynamic timelines.