GMP Documentation & Tech Transfer Lead

Lonza Biologics Tuas Pte Ltd; Singapore; On-site; Confidential; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Compensation programs

Global collaboration

Learning & development

Lonza Benefits

Job summary

Lonza Biologics Tuas Pte Ltd in Singapore seeks a Senior Technical Specialist to develop and manage GMP manufacturing documentation, support technology transfers and process campaigns, and lead investigations to ensure compliant, efficient production.

You will collaborate with Manufacturing, Quality Assurance, MSAT, Engineering, and customers to deliver high-quality technical deliverables while upholding data integrity and process excellence.

Qualifications

• Bachelor's degree in a life sciences or engineering field.
• Experience authoring and managing GMP-controlled manufacturing documents (MBRs, SOPs, CRs, risk assessments).
• Strong technical writing, documentation management, and cross-functional collaboration skills.

Responsibilities

• Lead development, revision, and lifecycle management of MBRs, SOPs, CRs, risk assessments, and other GMP docs for technology transfers and campaigns.
• Coordinate readiness activities with pre-campaign training, qualification support, and stakeholder alignment to ensure manufacturing execution.
• Lead complex manufacturing investigations including deviations, trend investigations, root cause analyses, product impact assessments, and CAPA development.
• Support manufacturing operations with deviation review, CAPAs, change controls, defective material management, audit preparation, and technical assessments.
• Collaborate with cross-functional teams (Manufacturing, QA, MSAT, Engineering, customers) to ensure timely completion of deliverables and regulatory compliance.
• Drive continuous improvement by enhancing documentation and processes, mentoring junior team members, and promoting data integrity.
• Provide technical expertise during customer interactions, regulatory inspections, and internal audits via documentation and presentations.

Skills

Technical writing

GMP documentation

Cross-functional collaboration

Root cause analysis

CAPA management

Data integrity

Change control

Education

Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Chemistry, Microbiology, Life Sciences or related discipline

Job description

Lonza Biologics Tuas Pte Ltd in Singapore seeks a Senior Technical Specialist to develop and manage GMP manufacturing documentation, support technology transfers and process campaigns, and lead investigations to ensure compliant, efficient production.

You will collaborate with Manufacturing, Quality Assurance, MSAT, Engineering, and customers to deliver high-quality technical deliverables while upholding data integrity and process excellence.