- Bioreactor Operations
- Media and Reagent Preparation
- Cell Banking & Subculturing
Role Summary
We are looking for a motivated Biotechnologist, you will execute routine and critical manufacturing operations within the Cell Culture (upstream) area, ensuring consistent production of clinical and/or commercial biologics. You will operate and maintain bioreactors and related equipment in compliance with GMP guidelines and SOPs, contributing to process reliability and product quality.
Key Responsibilities
- Bioreactor Operations:
- Prepare, set up, and operate single-use and stainless-steel bioreactors (from 50 L to 2 000 L scale).
- Monitor and adjust culture parameters (pH, DO, temperature, agitation) to maintain optimal cell growth.
- Media and Reagent Preparation:
- Formulate and sterilize culture media, feed solutions, and buffers.
- Perform buffer exchanges and feed additions according to batch protocols.
- Cell Banking & Subculturing:
- Thaw, expand, and maintain working and master cell banks under sterile conditions.
- Conduct viability and sterility checks (trypan blue exclusion, microscopic inspection).
- Sampling & In-Process Testing:
- Collect and process samples for cell density, viability, metabolite, and metabolomic analyses.
- Document results accurately in electronic batch records.
- Equipment Cleaning & Sterilization:
- Execute CIP/SIP procedures on reactors, tubing, and ancillary equipment.
- Maintain cleanroom attire discipline and adhere to gowning/ungowning protocols.
- Documentation & Compliance:
- Follow SOPs, batch records, and deviation/incident reporting processes.
- Participate in periodic audits, investigations, and continuous improvement initiatives.
- Cross-Functional Support:
- Collaborate with Purification, Quality, and Engineering teams to troubleshoot process deviations.
- Assist in scale-up activities and technology transfer to downstream processes.
Must-Have Qualifications
- Studied in Biotechnology, Biochemical Engineering, Microbiology, or related life-science field.
- Minimally internship experience of hands-on experience in mammalian cell culture or microbial fermentation at production scale.
- Familiarity with GMP, GCP, and GDP standards in a biologics manufacturing environment.
- Strong aseptic technique and cleanroom behavior.
- Experience with single-use bioreactor systems and associated control software (e.g., Sartorius Biostat, Ambr).
- Proficient in documentation.
We regret to inform that only shortlisted candidates will be notified.
EA Registration No: R22109832, LEE YAO HONG MALCOLM
Allegis Group Singapore Pte Ltd, Company Reg No. 200909448N, EA License No. 10C4544
