Apply: Senior/ Scientist, QC

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

Requirements

• 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

  R1443092