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Senior QC Analyst / QC Analyst (Biochem)

lonza · SG - Tuas

New
Mid 🇬🇧 English
ELISA PCR SDS-PAGE IEF Biacore cGMP Method validation Data integrity

Job description

About the role

Lonza is hiring a QC Analyst (Biochemistry) for its Quality Control team in Singapore. You will perform analytical testing, support method transfers and validations, troubleshoot laboratory methods and equipment, and contribute to continuous improvement in a GMP-regulated environment. The role is fully site-based.

Key responsibilities

  • Perform and prioritise testing of final product, in-process and stability samples according to approved methods, SOPs and cGMP requirements.
  • Execute biochemical and analytical methods including ELISA, PCR, SDS-PAGE, IEF potency assays, Biacore and other physicochemical techniques.
  • Support method transfers, method validations, equipment qualification and laboratory troubleshooting.
  • Document, review and maintain laboratory data and records in line with GMP and data integrity principles.
  • Investigate laboratory events such as OOS, deviations and analytical issues, supporting root cause analysis and technical reports.
  • Author and maintain quality documentation including change controls, SOPs, test methods and procedures.
  • Contribute to continuous improvement, laboratory operations, equipment maintenance, reagent preparation and technical training.

Required profile

  • Degree or higher qualification in Biochemistry, Biotechnology, Life Sciences, Pharmaceutical Sciences, Chemistry or a related discipline.
  • 0-5 years of Quality Control or laboratory experience in the biopharmaceutical, biotechnology or pharmaceutical industry.
  • Experience supporting method transfers, method validations, equipment qualification and laboratory investigations.

Required skills

  • Hands-on experience with ELISA, PCR, SDS-PAGE, IEF potency assays and Biacore.
  • Good understanding of cGMP, quality management systems, data integrity and global regulatory expectations (FDA, EMA, ICH).
  • Analytical, troubleshooting and problem-solving skills, with strong communication and a collaborative, safety-first mindset.

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 professional development.

Questions fréquentes

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Source : ats:workday

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Published 10 hours ago

Expires 1 month from now

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lonza

SG - Tuas