Ka Hern Tan

Production Associate with 4 years of Biopharmaceutical experience in Manufacturing, Qualification and Validation under Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) regulation. Excellent documentation skills under Quality Management System (QMS) guidelines. Experienced in using Digital Quality Management Software (TrackWise) and Resource Planning Application (SAP) // BSc Biotechnology degree from Imperial College London.

Upstream Production Biotechnologist specializing in GLP- and cGMP-regulated lab-scale (5L) cell expansion and industrial-scale (5kL to 50kL) cell culture fermentation. As team lead, I am capable of conducting and executing automated sterile production process operation, with expertise in QMS documentation under GDP guideline.

Overview of the qualities I possess:

• Shopfloor Management - Perform housekeeping and plant inspection to uphold compliance and audit readiness; ensure all equipment are subjected to timely calibration and preventive maintenance.
• Fermentation Expertise - Knowledge in monitoring cell culture growth (OD and WCW check), fermentation parameter control, metabolite analysis, harvesting and cell separation.
• Process Troubleshooting - Good understanding of block diagram, action expression details, phase transition and handshake of logic between recipes in Delta V DCS.
• Deviation Investigation - Participate in investigation for events such as parameter out-of-range and batch failure to identify potential root causes.
• Documentation Competency - Perform gap analysis for SOP, checklists and BMR; preparation of quality documents such as Risk Assessment, Impact Assessment, Change Control and CAPA report.
• Inventory Management - Ensure process order and reservation of raw materials and consumables are created and closed in SAP.
• Cross Functional Project Management - Participate in equipment IQ, PQ and RQ activities, analyze and compile generated data for preparation of report.
• Process Improvement - Execute production campaigns in cooperation with R&D at improved process parameters to achieve enhanced product yield; proactively perform comparative process metrics analysis and highlight potential causes for difference in performance between equipment.
• Process and Layout expertise - Ability to interpret Process Flow Diagram (PFD) and Piping & Instrumentation Diagram (P&ID) significant for supporting modification engineering works.

Strong educational background in protein engineering, bacterial metabolic and network engineering as well as bioprocessing. My final year research project involved evolving an industrial-relevant enzyme via site saturation mutagenesis and E.coli based anaerobic selection system to achieve enhanced reduction specificity towards a wide range of ketones.

• Dean’s List - Top 10% in academic year 2015/16 cohort.
• Completion of interdepartmental energy-sustainability design project under Imperial College London Estates Facilities Board targeting to reduce energy emission by 10% each month.
• Knowledge in market analysis, patenting and intellectual property protection strategy from bio-entrepreneurship courses.
• Acquired insight into pharmaceutical life cycle management, with emphasis on acceleration of drug discovery and development stage.