QC Analytical Expert - Biotechnology
|Job Title:||QC Analytical Expert - Biotechnology|
|Contact Name:||Jolene Lee|
|Job Published:||August 01, 2021 13:54|
Our client is a leading biotechnology company focused on clinical development of treatments for Infectious Diseases. They are looking to recruit a highly motivated Quality Control Analytical Expert to manage analytical testing and data verification activities for early as well as late-stage biologics in its cGMP-compliant laboratories.
You will set up the Quality Control Analytical department, supervise and mentor a QC Analytical team supporting analytical method development, method validation and release testing (RM, IPQC, DS, DP). You will ensure QC procedures are in accordance with the stringent regulatory guidelines as well as perform statistical analysis, data verification and analytics supporting both early to late-stage biologics.
You will ensure risk assessments are performed for all the QC analytical test methods and drive the team for operational excellence. Ensure timely analytical testing support & closure of Deviations, investigations, CAPA, OOS, change controls. You will work closely with QA and IT to ensure applicable data integrity compliance within QC operations. You will also liaise with Product Development scientists on the impact of process changes to drug substance quality.
Ideally, you have more than 3 years of relevant industry experience with proven track record of QC method development, qualification, validation, troubleshooting, and transfer as required by ICH/FDA/EMA guidelines and knowledge of current OECD GLP/cGMP as they apply to analytical laboratory practices. You possess a Masters/PhD in Biochemistry, Cell and Molecular Biology, Biological Engineering or related field.
You have 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 to support Biologic Drug Substance and Drug Product. You 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.
You are independent with excellent verbal and written communication skills as well as the ability to function in a fast-paced, team-oriented environment.
Singapore Employment Agency Licence No: 16S8069