Production Scientist

CELLVEC PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A biotechnology manufacturing company in Singapore is seeking a process technician to support GMP manufacturing and research activities. The successful candidate will perform laboratory testing, support validation processes, and assist in upstream and downstream cell culture techniques. Applicants should have a degree in Science or Engineering, along with relevant experience in a cleanroom environment. Strong communication skills and a team-oriented approach are essential for success in this role.

Qualifications

• 1 to 3 years relevant work experience in a similar manufacturing industry or cleanroom environment.
• Knowledge of Viral Vector manufacturing and Gene Therapy application is an added advantage.
• Flexible to adjust the schedule to support GMP manufacturing and R&D trial Runs.

Responsibilities

• Perform laboratory testing and equipment monitoring in GMP manufacturing and R&D settings.
• Support protocol preparation and validations for development studies.
• Assist in process development to create scalable processes with improved product yield.

Skills

Aseptic technique

Communication

Team-oriented

Education

Degree/Diploma in a related Science/Engineering discipline

Tools

Chromatography techniques

Tangential flow filtration techniques

Job description

Key responsibilities:

• Learn and perform well-defined procedures in GMP manufacturing setting and Research and Development Settings
• Perform equipment monitoring and basic housekeeping
• Perform laboratory testing (e.g. pH/ conductivity/Cell density / Viability, Mycoplasma, PCR test and Flow cytometry … etc.)
• Perform routine Clean room sanitization tasks to maintain the Clean room ISO standards
• Demonstrate aseptic technique in the handling of product/ materials and requirement to participate in Aseptic process Simulations.
• Multi-task exposure on cGMP manufacturing and Validation task and Research and Development trail runs.
• Support for Protocol preparation, Execution, and summary report for Validation run and development studies
• Attain full competency in the performance of all operations as assigned.
• Become a technical process expert by exhibiting basic understanding of critical process/operational parameters and target/acceptable ranges, as well as interactions between different process parameters.
• Use Standard Operating Procedures (SOPs), logbooks & Batch Manufacturing Records (BMR’s) effectively & competently
• Taking part in the internal and external audit.
• Support for Change control, Deviations, investigations and CAPA initiation and closure
• Assist in process development, in creating scalable processes with improved product yield and reduced manufacturing systems costs
• Support Facilities Engineering team to perform maintenance, troubleshooting, calibration, and repair instrumentation (where applicable).

Cell Culture (Upstream)

• Skill and knowledge of aseptic technique for thaw and subculture stages using T flasks and Cell factories, etc.
• Knowledge of handling Cell culture, trypsinization, Centrifugation and resuspension. Cell Culture Passaging from flask / Cell factories.
• Benchtop set up for Cell culture supernatant Clarification

Purification (Downstream)

• Skill and knowledge of small-scale column chromatography techniques, tangential flow filtration techniques, Final Filling techniques in BSC and Isolators
• Knowledge in handling single use chromatography columns and tangential flow filtration skids.

Key requirements:

• Degree/Diploma in a related Science/Engineering discipline
• 1 to 3 years relevant work experience in a similar manufacturing industry or cleanroom environment
• Knowledge of Viral Vector manufacturing and Gene Therapy application is an added advantage.
• Knowledge of cGMP applications
• Positive team-oriented attitude
• Strong communication and interpersonal skills
• Flexible to adjust the schedule to support GMP manufacturing and R&D trial Runs.