Site Name: Singapore - Jurong
Posted Date: Nov 7 2024

Purpose

To plan, organise and carry out experimental work with the objective of improving existing processes on plant, Evaluating raw materials, Providing troubleshooting support to the operations department. Provide technical input to the Secondary interface and ensure that product is fit for purpose. Provide support for commissioning and validation on plant.

Key Responsibilities Area

• Ensure process optimisation for a specific product to make improvements to processes with respect to yield, quality, output, cost savings, robustness etc. in line with GMP requirements and ensure suitability for Secondary process performance
  
• Undertake troubleshooting of problems relating to the plant/ processes to ensure the effective and prompt resolution of issues/ salvage of batch/ development of novel re-work methods for treatment of sub-standard batches
  
• Ensure proper documentation and filing for a specific product (includes laboratory notebooks, technical memos, analytical raw data, risk assessments, etc.) in compliance with GMP and GLP requirements
  
• Ensure the provision of first-line product-specific technical support to its customers (internal and external)
  
• Provide technical support for routine manufacture and to commissioning teams in the commissioning of established/ new products, as well as conduct training in process chemistry to the relevant parties
  
• Evaluate the quality of raw materials and intermediates to ensure that it meets company’s specifications, and liaise with external suppliers to provide feedback on the quality of materials
  
• Work closely with respective product value streams (e.g. Product Technical Review Teams (PTRT)) to ensure full visibility and alignment of all activities and change/ risk assessments
  
• Support technical, genotoxic and material risk assessment for change implementation and maintenance of the control strategy throughout product lifecycle
  
• Support trending and review of key process parameters and attributes as part of Continued Process Verification (CPV)
  
• Provide technical support for routine process decontamination activities (includes identify process residues, support cleaning risk assessment, cleaning limits calculation, support unknown peak investigation, improvement to current decontamination method, etc)
  

Skills, Knowledge & Experience

• At least a degree in Chemistry or equivalent
  
• Experience in a laboratory environment in the pharmaceutical industry or equivalent is desired
  
• Sound knowledge of organic, organometallic chemistry
  
• Sound analytical and plant knowledge
  
• Sound knowledge of c GMP/ GLP
  
• Knowledge of laboratory safety and hazards
  
• General business & financial awareness
  
• Good communication skills
  

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