Biotechnologist II

The Biotechnologist II performs critical day-to-day functions associated with cGMP manufacturing operations within a commercial biologics production facility. This role involves executing unit operations across upstream, downstream, or central service processing streams, working closely with engineering and leadership teams on equipment setup, calibration, rework, and quality testing. The successful candidate will ensure all production tasks and batch documentation are executed accurately, thoroughly, and on schedule while strictly adhering to cGMP, safety, and quality standards in a cost-effective manner. Key Responsibilities Operations & Technical Execution cGMP Execution: Perform routine bioprocess operations in compliance with cGMP guidelines and safety standards across designated processing streams: Upstream: Vial thawing, inoculation, cell culture monitoring, and harvest recovery.

Downstream: Preparative chromatography, tangential flow filtration (TFF), ultrafiltration/diafiltration (UF/DF), and final filling operations.

Central Services: Large-scale buffer and media preparation, autoclave operation, glass wash, automated cleaning processes (CIP/SIP), and raw material sampling.

Equipment & Facility Setup: Assist engineers and technical staff with equipment set-up, routine calibration, troubleshooting, and plant maintenance/upkeep during assigned shift operations.

Task Management: Execute daily operational tasks assigned by the Lead Biotechnologist or Manufacturing Supervisor to maintain continuous operational readiness.

Inventory Control: Monitor and maintain localized inventory levels of consumables and raw materials to minimize operational downtime and waste.

Training & Compliance: Ensure all individual training requirements remain current and fully completed.

Quality & Documentation Batch Records: Accurately complete batch production records, logbooks, and operational documentation in a timely, legible, and compliant manner.

Documentation Review: Perform peer reviews of completed batch documentation for accuracy, completeness, and timely error resolution.

Audit Readiness: Support production teams in preparation for internal quality reviews as well as external regulatory audits and inspections.

Deviation Escalation: Identify and report processing anomalies, quality events, or equipment deviations to the Lead Biotechnologist or Manufacturing Supervisor in a timely manner.

Safety & Environment EHS Adherence: Strictly enforce and comply with all Environmental Health & Safety (EHS) policies, procedures, and safety standards across all processing areas.

Schedule & Operational Support Schedule Execution: Adhere to defined shift-based production schedules and target outputs.

Issue Escalation: Promptly escalate unplanned downtimes, equipment failures, or schedule risks to shift supervisors to ensure minimal impact on production timelines.

Requirements & Qualifications Education: Diploma or Bachelor’s Degree in Biotechnology, Chemical Engineering, Biological Sciences, Pharmacy, or a related scientific discipline.

Experience: 1–3 years of hands-on experience in a cGMP biomanufacturing or pharmaceutical production environment.

Technical Skills: Familiarity with upstream (cell culture/fermentation) or downstream (chromatography/filtration) unit operations, or central service operations (buffer/media prep).

Good understanding of cGMP regulations, cleanroom protocol, and GDP (Good Documentation Practices).

Operational Attributes: Strong attention to detail, excellent technical documentation skills, and the ability to troubleshoot operational challenges on the floor.

Work Schedule: Ability to work on assigned shifts (including standard shifts or rotating patterns) in an onsite manufacturing environment located in Tuas, Singapore.