Senior Biologics Manufacturing Specialist — GMP & Process Lead

AbbVie; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

AbbVie in Singapore is seeking a skilled professional to ensure operational efficiency by managing technical documentation, addressing non-conformances, and implementing corrective actions. You will streamline processes and drive continuous improvement across manufacturing operations while maintaining compliance with regulatory standards.

Responsibilities include leading change management, developing training modules, and collaborating on quality systems such as Trackwise, LIMS, and SAP.

Qualifications

• Master or Degree with at least 5-7 years relevant experience in Biologics Production facility, or equivalent.
• Good working knowledge of cGMP and regulatory requirements related to Manufacturing is preferred.
• Strong working knowledge of GMP systems such as Trackwise, SAP, LIMS, MES systems are preferred.
• Experience with cGMP documentation and record maintenance.
• Experience with Regulatory inspections is required.
• Strong ability to lead and drive cross-functional teams.
• Posssesses a positive work attitude and a strong determination to complete tasks efficiently.
• Agility, capable of performing under pressure, and able to address various priorities.
• Good presentation and strong technical writing skills.

Responsibilities

• Manage technical documentation and investigate non-conformances.
• Develop and implement corrective and preventive actions with Ops and cross-functional teams.
• Lead change processes to enhance operations and support trainings.
• Collaborate on electronic batch records creation, revision and improvement.
• Prepare for regulatory inspections and internal audits.
• Engage in continuous operational improvement and regular GEMBA walkdowns.

Skills

Technical writing

Cross-functional collaboration

Leadership

Agility under pressure

Education

Master's degree in Biologics Production

Tools

Trackwise

LIMS

SAP

POMSnet

Delta-V

MES systems

Job description

AbbVie in Singapore is seeking a skilled professional to ensure operational efficiency by managing technical documentation, addressing non-conformances, and implementing corrective actions. You will streamline processes and drive continuous improvement across manufacturing operations while maintaining compliance with regulatory standards.

Responsibilities include leading change management, developing training modules, and collaborating on quality systems such as Trackwise, LIMS, and SAP.