Based in Singapore Analytical Science & Technology Biopharmaceutical Sector
The position requires the a highly motivated individual to be part of its small, dynamic and specialized research team focused on the development of novel therapeutics for infectious disease as well as bio-manufacturing platforms to enable rapid bench to bedside translation. The role will require the incumbent to work together with the team n operating a bioanalytical laboratory, conducting GxP studies and developing innovative analytical platforms to support GMP bioproduction for Biologics Licensing. Responsibilities for Scientist, Quality Control
Analytical testing and data verification supporting both early to late stage biologics in cGMP-compliant laboratories
Improve QC test design for drug substance release and in-process testing.
Work with Quality Assurance to ensure that drug substances meet set standards of quality, reliability, and performance, including identifying risk for errors and reporting on investigations and audits when requested
Liaise with Product Development scientists on the impact of process changes to drug substance quality
Supervise and mentor a subset of junior associates within the Analytics team to ensure they perform their duties in line with established company procedures
An advanced degree (e.g. Masters, Ph.D.) in biochemistry, cell and molecular biology, biological engineering or related field is required
Minimum of three years of related industry experience
Proven track record of QC method development, qualification, validating, troubleshooting, and transfer as required by ICH/FDA/EMA guidelines and knowledge of current OECD GLP/cGMP as they apply to analytical laboratory practices.
Expertise and in-depth knowledge of analytical techniques required for biologics manufacturing and release, including but not limited to, liquid chromatography mass spectrometry (LC-MS), Capillary electrophoresis (CE) and Bioassays
Possess high standards of consistency and quality, the initiative to mentor and train, and the analytical rigor to find the root cause of challenging manufacturing problems
Take initiative and demonstrated accountability in a fast-paced environment