Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
5 Years
Description
- Perform and prioritize testing of final product, in-process, and stability samples in accordance with approved test methods, SOPs, and cGMP requirements.
- Execute biochemical and analytical methods including ELISA, PCR, CE, SDS-PAGE, IEF, icIEF, potency assays, Biacore, and other physiochemical techniques.
- Support method transfers, method validations, equipment qualification activities, and laboratory troubleshooting to ensure operational readiness and compliance.
- Document, review, and maintain laboratory data and records in accordance with GMP requirements and data integrity principles.
- Investigate laboratory events including OOS, deviations, and analytical issues, supporting root cause analysis and technical report generation.
- Author and maintain quality documentation including Change Controls, SOPs, test methods, and laboratory procedures.
- Contribute to continuous improvement initiatives, laboratory operations, equipment maintenance, reagent preparation, and technical training activities.
Qualifications
Highest qualification: University
- Degree, or higher qualification in Biochemistry, Biotechnology, Life Sciences, Pharmaceutical Sciences, Chemistry, or a related discipline.
- At least 5 years of Quality Control or laboratory experience within the biopharmaceutical, biotechnology, or pharmaceutical industry.
- Hands-on experience with biochemical and analytical techniques such as ELISA, PCR, CE, SDS-PAGE, IEF, icIEF, potency assays, and Biacore.
- Experience supporting method transfers, method validations, equipment qualification, and laboratory investigations.
- Good understanding of cGMP requirements, quality management systems, data integrity principles, and global regulatory expectations including FDA, EMA, and ICH guidelines.
- Strong analytical, troubleshooting, problem-solving, and quality decision-making skills with the ability to work independently and prioritize effectively.
- Strong communication and interpersonal skills with a collaborative mindset and commitment to safety, quality, and operational excellence.