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Job Details

Location
Singapore
Salary
-
Job Type
Permanent
Ref
BH-161122
Contact
Gilbert Khor
Contact email
Email Gilbert
Contact phone
65 6692 0742
Posted
3 months ago
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