Senior Technical Specialist, MM (MFG)

Lonza Group Ltd.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Benefits offered by this job

Dynamic culture

Inclusive workplace

Compensation programs

Global collaboration

Learning & development

Job summary

Lonza Group Ltd. in Tuas, Singapore, is seeking a rigorous documentation and manufacturing specialist to lead MBR/SOP lifecycle and GMP documentation for technology transfers and campaigns.

You will coordinate readiness activities, support investigations, and collaborate with QA, MSAT, Engineering, and customers to ensure compliant, timely execution. The role emphasizes strong technical writing, cross-functional leadership, and mentorship in a dynamic biopharma environment with opportunities for

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Chemistry, Microbiology, Life Sciences, or related field.
• Experience in biopharmaceutical manufacturing, manufacturing support, technical operations, process engineering, MSAT, or GMP documentation.
• Strong experience authoring and managing MBRs, SOPs, Change Requests, risk assessments, and GMP-controlled docs.
• Solid understanding of GMP, deviation investigations, CAPA, root cause analysis, and manufacturing quality systems.
• Excellent technical writing, documentation management, communication, and presentation skills.
• Proven ability to lead cross-functional projects, manage priorities, influence stakeholders, and mentor juniors.
• Analytical, problem-solving, and continuous improvement mindset with data integrity and compliance focus.

Responsibilities

• Lead development, revision, and lifecycle management of MBRs, SOPs, CRs, risk assessments, and GMP docs for transfers and campaigns.
• Coordinate readiness activities: training, qualification support, and stakeholder alignment for manufacturing execution.
• Lead investigations (deviations, trend studies, CAPA, impact assessments) to support product disposition.
• Support operations with deviation review, CAPAs, change controls, material management, and audits.
• Collaborate with Manufacturing, QA, MSAT, Engineering, and customers to meet technical deliverables and compliance.
• Drive continuous improvement by updating docs, optimizing processes, mentoring teammates, and ensuring data integrity.
• Provide technical input during customer interactions, regulatory inspections, and internal audits.

Skills

MBR authoring

SOP authoring

Deviation investigations

CAPA management

Technical writing

Cross-functional leadership

Regulatory compliance

Education

Bachelor's degree in Chemical Engineering or related field

Tools

GMP Documentation Systems

MSAT tools

Quality Management System (QMS)

Job description

Posted Job Advert Location: Tuas, Singapore

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.

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference.

Here, you will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.

Join us. Be you.

Every day, our teams across the world work together to turn scientific breakthroughs into life-changing medicines that reach up to 100 million patients a year.

Lonza is a place where people can make a unique impact, grow their careers and belong. You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients