Senior Analyst, Quality Control

About the role

Lonza is hiring a Senior Analyst, Quality Control in Tuas, Singapore, to join its Quality Control team. You will perform and oversee testing, support method transfers and validations, lead laboratory investigations and act as a subject matter expert for analytical methods in a GMP-regulated environment.

Key responsibilities

• Perform and review testing of raw materials, in-process samples, environmental monitoring samples and finished products according to approved methods, SOPs and cGMP requirements.
• Support method transfers, method validations, equipment qualification and troubleshooting.
• Lead OOS, deviation and laboratory investigations, including root cause analysis, impact assessment and technical reporting.
• Author and maintain documentation such as change controls, test methods, SOPs, protocols and technical reports.
• Train colleagues and act as a technical resource on analytical methods and compliance.
• Support lab operations including reagent and standard preparation, sample management, equipment maintenance, inventory control and housekeeping.
• Drive continuous improvement, operational excellence and data integrity initiatives.

Required profile

• Degree or diploma in a relevant science (Chemistry, Biochemistry, Biotechnology, Microbiology, Pharmaceutical Sciences, Life Sciences) or equivalent.
• Quality Control experience in a GMP-regulated pharmaceutical, biotechnology, cell therapy or life sciences environment.
• Hands-on experience in product testing, raw material testing, microbiology/environmental monitoring or cell therapy QC.
• Experience supporting method validation, method transfer, equipment qualification and technical documentation.
• Strong analytical, problem-solving, communication and stakeholder management skills, able to work independently in a fast-paced GMP setting.

Required skills

• Analytical techniques such as HPLC, ELISA, PCR, CE, SDS-PAGE, IEF/icIEF, spectroscopy, TOC, osmolality, flow cytometry and environmental monitoring.
• Compendial testing and strong knowledge of cGMP, laboratory investigations, data integrity and quality systems.

What we offer

• An agile career and dynamic working culture in an inclusive, ethical workplace.
• Compensation programs that recognise high performance.
• Collaboration with global cross-functional teams and ongoing learning and development.
• Full list of global benefits available through the employer.