Job Description

Quality Control Engineer

SCG is a leading biotechnology company focusing on the development of novel immunotherapies in infections and its associated cancers. The company targets the most common cancer-causing infections: helicobacter pylori, human papillomavirus, and hepatitis B, and develops a broad and unique pipeline of T cell therapies, antibodies, and therapeutic vaccines against infections and to prevent and cure its associated cancers. Established and headquartered in Singapore, SCG combines regional advantages in Singapore, China and Germany, covering the entire value chain from innovative drug research and discovery, manufacturing, clinical development and commercialization. SCG collaborates with leading scientists and researchers to bring first-in-class and best-in-class medical products/technologies to enhance innovation in medical product development.

Key responsibilities

The QC Engineer will be responsible for daily quality control activities and ensure all activities are according to SOP and GMP requirements including liaising with external manufacturing and testing labs.

• Perform testing of the in-process, final product, and stability samples according to SOP and GMP requirements.
• Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment
• Prepare and review external and internal protocols and other documentation as required to support external testing lab and manufacturing services. (Ensure BMR records are up-to-date, complete and accurate; Monitor microbial testing program; Verify test results).
• Support regulatory submissions.
• Develop, write and execute methods, protocols, reports and other related documents.
• Perform and complete Change Control, Investigations, and Corrective/Preventive Actions associated with QC and/or process deviations.
• In collaboration with the Quality Assurance department, provide technical assistance in the development, and maintenance of raw materials and finished product specifications.
• Prepare and present continuous improvement projects to the management
• Performs special assignments in assay tech transfer, validation, or other technical projects as assigned by the management.

• Minimum Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or related life Sciences or Technology with about 2-5 years of experience in QC lab in the pharmaceutical or biotechnology industry.
• Comprehensive knowledge of cGMPs, GLPs and data integrity requirements for Quality Control laboratories.
• Excellent verbal, written, and interpersonal communication and presentation skills.
• Knowledgeable of FDA regulations and ICH Guidelines regarding the manufacture of biological including regulatory inspection experience.
• Effective problem-solving skills and good understanding of risk-based decision framework
• Experience with method validation and technology transfers
• Experience with equipment qualifications and analytical instrument/software validations
• Experience with flow cytometry, qPCR, cell culture, immunology and assay development/validation
• Experience with Cell/Gene Therapy preferred.