Senior Technical Specialist, MCO (Mammalian)

LONZA BIOLOGICS TUAS PTE. LTD.; Singapore; On-site; SGD 90,000 - 150,000; Full time

Benefits offered by this job

Agile career culture

Inclusive and ethical workplace

Professional development opportunities

Global cross-functional collaboration

Job summary

Lonza in Tuas, Singapore, seeks a Senior Technical Specialist to develop and manage manufacturing documentation, support technology transfers, and lead complex investigations to uphold GMP standards. You will collaborate with cross-functional teams to ensure timely, compliant deliverables and drive continuous improvement in manufacturing documentation.

You will coordinate readiness activities, contribute to CAPAs and change controls, and provide technical expertise during audits and inspections.

Qualifications

• Strong technical writing skills and GMP documentation experience.
• Experience authoring and managing GMP-controlled docs like MBRs, SOPs, CRs, risk assessments.

Responsibilities

• Lead development, revision, and lifecycle management of MBRs, SOPs, CRs, and risk assessments.
• Coordinate operational readiness activities: training, qualification support, stakeholder alignment.
• Lead complex investigations: deviations, trend analyses, root cause analysis, CAPA development.
• Support manufacturing operations: deviations review, CAPAs, change controls, audit prep.
• Collaborate with Manufacturing, QA, MSAT, Engineering and customers to meet regulatory requirements.
• Drive continuous improvement by improving docs and processes and mentoring teammates.

Skills

Technical writing

Education

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

Job description

Location: Tuas, Singapore

Be part of Lonza's Manufacturing Technical Team (MTT), where you will play a critical role in enabling successful manufacturing operations through technical documentation and operational readiness. As a Senior Technical Specialist, you will develop and manage manufacturing documentation, support technology transfers and process campaigns, and lead complex technical investigations to ensure manufacturing excellence. This role requires strong technical writing, cross-functional collaboration, and GMP expertise to support safe, compliant, and efficient manufacturing operations.

What you will get

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Opportunities to collaborate with global cross-functional teams.
• Ongoing learning and professional development opportunities.
• Our full list of global benefits can be found here: Lonza Benefits.

What you will do

• Lead the development, revision, and lifecycle management of Master Batch Records (MBRs), Standard Operating Procedures (SOPs), Change Requests (CRs), risk assessments, and other GMP manufacturing documentation supporting technology transfers and process campaigns.
• Coordinate operational readiness activities by managing documentation, pre-campaign training, equipment and material qualification support, and stakeholder alignment to ensure successful manufacturing execution.
• Lead complex manufacturing investigations, including deviations, trend investigations, root cause analyses, product impact assessments, and CAPA development to support timely product disposition.
• Support manufacturing operations by managing operational activities such as deviation review, CAPAs, change controls, defective material management, audit preparation, and manufacturing technical assessments.
• Collaborate with cross-functional teams including Manufacturing, Quality Assurance, MSAT, Engineering, and customers to ensure timely completion of technical deliverables and regulatory compliance.
• Drive continuous improvement initiatives by enhancing manufacturing documentation, optimizing operational processes, mentoring junior team members, and promoting data integrity and operational excellence.
• Provide technical expertise during customer interactions, regulatory inspections, and internal audits through effective communication, presentation, and technical documentation support.

What we are looking for

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Chemistry, Microbiology, Life Sciences, or a related scientific discipline.
• Experience in biopharmaceutical manufacturing, manufacturing support, technical operations, process engineering, MSAT, or GMP technical documentation.
• Strong experience authoring and managing Master Batch Records (MBRs), SOPs, Change Requests, risk assessments, and other GMP-controlled manufacturing documents.
• Good understanding of manufacturing processes, GMP requirements, deviation investigations, CAPA management, root cause analysis methodologies, and manufacturing quality systems.
• Excellent technical writing, documentation management, communication, and presentation skills with the ability to translate complex manufacturing processes into clear operational instructions.
• Demonstrated ability to lead cross-functional projects, manage competing priorities, influence stakeholders, and mentor junior team members in a dynamic manufacturing environment.
• Strong analytical, problem-solving, and continuous improvement mindset with a commitment to data integrity, compliance, and operational excellence.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.