Senior Analyst, QC (Biochemistry)
The Senior QC Analyst at Lonza will be responsible for the biochemistry area in the QC lab to support lot release activities. Key responsibilities include performing analytical techniques like ELISA, HPLC, and PCR, managing data integrity, and conducting OOS investigations. The role requires 8 years of biopharmaceutical QC experience and strong familiarity with GMP and FDA/EMEA guidelines. The candidate will also support method transfers, validation activities, and team training.
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Experience
8+ years
Function
Quality Assurance
Work mode
Onsite, Singapore
Company
Tier 2
What you will work on
The Senior QC Analyst at Lonza will be responsible for the biochemistry area in the QC lab to support lot release activities. Key responsibilities include performing analytical techniques like ELISA, HPLC, and PCR, managing data integrity, and conducting OOS investigations. The role requires 8 years of biopharmaceutical QC experience and strong familiarity with GMP and FDA/EMEA guidelines. The candidate will also support method transfers, validation activities, and team training.
Must haves
- 8 years of QC/Quality experience in biopharmaceuticals
- Degree or higher
- Familiarity with FDA, EMEA, ICH guidelines and GMP quality systems
- Experience with ELISA, PCR, CE, SDS-PAGE, IEF/icIEF, HPLC, spectroscopy
- Ability to support OOS and deviation investigations
Tools and skills
About the company
Global life sciences leader, but not a tier 1 software/tech giant in engineering context.