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- Posted
- 3 days ago
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Job description
About the Role
We are seeking a Lead Engineer specializing in MSAT (Manufacturing Science and Technology) for Cell & Gene Therapy to join our team at Lonza's Singapore site in Tuas. This role is essential in driving technology transfers and manufacturing excellence within a GMP/ATMP environment.
Key Responsibilities
- Lead and facilitate the transfer of customer manufacturing processes into Lonza Bioscience Singapore, ensuring seamless integration.
- Collaborate closely with multifunctional teams including Manufacturing, Quality Assurance, Quality Control, Validation, Supply Chain, and Project Management to enable successful pilot, clinical, and commercial manufacturing runs.
- Design and implement scale-down experiments and process fit assessments to support technology transfer and scale-up activities.
- Provide technical supervision on the manufacturing floor during GMP operations, troubleshoot process deviations, and spearhead investigations.
- Continuously monitor process performance to maintain consistency across production runs and identify opportunities for improvements.
- Author, review, and maintain process documentation such as protocols, reports, and change controls.
- Support factory start-up initiatives as well as regulatory inspections and audits.
Qualifications and Experience
- Demonstrated expertise in cell and gene therapy, aseptic manufacturing, and GMP/ATMP standards.
- Practical hands-on experience with adherent human cell culture processes.
- Experience managing deviations, change control procedures, and CAPA systems, preferably using TrackWise software.
- Strong competency in data analysis leveraging Excel and statistical tools.
- Familiarity with Lean, Six Sigma methodologies, and structured problem-solving techniques.
- Effective communication skills, proactive attitude, and the ability to excel in dynamic, cross-functional teams.
Employee Benefits and Perks
- Dynamic and agile career development within an innovative company culture.
- An ethical and inclusive workplace encouraging diversity.
- Competitive compensation programs rewarding high performance.
- Convenient daily company shuttle service from MRT stations near your residence to the Tuas facility.
- Fully-paid medical insurance coverage, plus options to enroll family members at reduced premium rates.
About Lonza
Lonza is a global leader in life sciences with over 30 facilities across five continents. Our mission is to manufacture the medicines of tomorrow by fostering collaboration, accountability, excellence, passion, and integrity within a diverse and inclusive workforce. We invite you to contribute your ideas and help shape the future of healthcare therapies.
Level
Lead
Industry
Biotechnology