Senior Biotechnologist — cGMP Manufacturing

Lonza Biologics Tuas Pte Ltd

Singapore

Presencial

Confidential

Jornada completa

Hace 2 días
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Ventajas ofrecidas por este puesto de trabajo

Daily bus service
Fully paid medical insurance
Shift allowances
Learning and development
Lonza global benefits

Descripción de la vacante

Lonza Biologics Tuas Pte Ltd in Tuas, Singapore is seeking a Senior Biotechnologist to lead cGMP manufacturing activities, ensure aseptic and cleanroom compliance and support complex investigations. You will complete batch records, perform environmental monitoring and drive process improvements while mentoring junior team members.

The role requires hands-on biopharmaceutical manufacturing experience, strong data integrity practices, and the ability to operate in a rotating 12-hour shift in a GMP

Formación

  • Degree or equivalent qualification or experience in Biotechnology, Biochemistry, Life Sciences, Engineering or a related discipline.
  • Demonstrated hands-on experience in biopharmaceutical manufacturing or a comparable GMP-regulated manufacturing environment.
  • Strong technical knowledge of biopharmaceutical processing, aseptic techniques and cleanroom operations.
  • Sound understanding of cGMP, critical process parameters, quality systems and data integrity requirements.
  • Experience in process or equipment troubleshooting, deviation investigations, CAPAs and change controls.
  • Strong communication, problem-solving and teamwork skills, with the ability to coach and guide colleagues.
  • Ability to work in a cleanroom manufacturing environment and perform a rotating 12-hour shift pattern.

Responsabilidades

  • Execute cGMP manufacturing activities, ensuring compliance with aseptic techniques, cleanroom practices and approved procedures.
  • Complete and review Batch Records, logbooks and GMP documentation accurately and on time, maintaining data integrity.
  • Perform environmental monitoring, equipment preparation, cleaning and routine production support activities.
  • Monitor critical process parameters, troubleshoot equipment and process issues, and elevate non-routine events.
  • Support complex deviation investigations, CAPAs, change controls and work notifications through electronic systems such as DMS, LIMS and TrackWise.
  • Coach and mentor junior team members, maintaining training compliance and supporting technical competency development.
  • Drive continuous improvement initiatives and take on additional operational responsibilities, including laboratory oversight when assigned.

Conocimientos

Biotechnology
Aseptic techniques
Cleanroom operations
GMP compliance
Data integrity
Problem solving
Coaching/mentoring

Educación

Degree in Biotechnology or Life Sciences

Herramientas

LIMS
DMS
TrackWise
Batch records management

Descripción del empleo

Lonza Biologics Tuas Pte Ltd in Tuas, Singapore is seeking a Senior Biotechnologist to lead cGMP manufacturing activities, ensure aseptic and cleanroom compliance and support complex investigations. You will complete batch records, perform environmental monitoring and drive process improvements while mentoring junior team members.

The role requires hands-on biopharmaceutical manufacturing experience, strong data integrity practices, and the ability to operate in a rotating 12-hour shift in a GMP

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