GMP Manufacturing Documentation & Tech Transfer Lead

Lonza Group Ltd.; Singapore; On-site; Confidential; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Performance-based pay

Global collaboration

Learning & development

Lonza Benefits

Job summary

Lonza Tuas, Singapore is seeking a Senior Technical Specialist to drive GMP manufacturing documentation, tech transfers and process campaigns. You will lead Master Batch Records (MBRs), SOPs, Change Requests (CRs), risk assessments and investigations to ensure compliant manufacturing.

This role requires strong technical writing, cross-functional collaboration and data integrity, contributing to Lonza's global manufacturing excellence and quality systems.

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Chemistry, Microbiology, Life Sciences, or related field.
• Experience with biopharmaceutical manufacturing, GMP documentation, tech transfers or process campaigns.
• Strong technical writing and documentation management skills.

Responsibilities

• Lead development and lifecycle management of MBRs, SOPs, CRs and risk assessments.
• Coordinate readiness activities for campaigns including training and qualification support.
• Lead investigations (deviations, root cause analyses, CAPA) and support product disposition.
• Support operations with deviation reviews, CAPAs, change controls and audit prep.
• Collaborate with Manufacturing, QA, MSAT, Engineering and customers to ensure timely deliverables and regulatory compliance.
• Drive continuous improvement of documentation and processes.

Skills

Technical writing

GMP

Cross-functional collaboration

Data integrity

Root cause analysis

Education

Bachelor's degree in Chemical Engineering or related

Tools

MBR management

SOP authoring

Job description

Lonza Tuas, Singapore is seeking a Senior Technical Specialist to drive GMP manufacturing documentation, tech transfers and process campaigns. You will lead Master Batch Records (MBRs), SOPs, Change Requests (CRs), risk assessments and investigations to ensure compliant manufacturing.

This role requires strong technical writing, cross-functional collaboration and data integrity, contributing to Lonza's global manufacturing excellence and quality systems.