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Senior Chemistry Professional

2 weeks ago

Singapore beBeeChemist Full time
Job Overview

This role plays a crucial part in delivering high-quality analytical solutions through exceptional expertise in biologic chemistry.

As a Chemist II, you will contribute significantly to our ambitious projects, ensuring flawless quality control operations that meet regulatory compliance and data integrity principles.

You will collaborate closely with other functions, promoting a proactive business partnership to successfully implement method qualifications and validation strategies.

The ideal candidate will have a strong understanding of international regulatory requirements and be able to communicate effectively with cross-functional teams.

Responsibilities
  • Support new equipment qualification, lab computerized systems, and chemistry lab setup.
  • Perform transfer, verification, and validation of laboratory procedures.
  • Prepare technical documentation, including protocols, analytical write-ups, standard operating procedures, specifications, investigations, and reports.
  • Analyze incoming goods, intermediates, and finished products under cGMP conditions for QC release and stability studies.
  • Lead the testing process from sampling to the release of raw materials, drug substances, process aids, and packaging materials.
  • Ensure timely and compliant testing of all chemistry-related analyses, including HPLC, GC, and stability analysis.
  • Manage daily laboratory operations, ensuring compliance with GMP standards.
  • Identify and address compliance gaps with updated pharmacopoeia and regulations.
  • Lead laboratory investigations, deviations, and ensure timely closure in line with quality management systems.
  • Review analytical and laboratory data for accuracy and compliance.
  • Perform maintenance and calibrations on laboratory equipment.
  • Troubleshoot technical issues related to analytical equipment and methods.
  • Manage QC chemical, reference standard, and consumable stock levels.
  • Train fellow chemists, serving as a mentor and expert.
  • Maintain a detailed understanding of international regulatory requirements.
Requirements

This position requires:

  • A university degree or equivalent experience in chemistry, biochemistry, or life sciences.
  • At least 5-7 years of proven experience in the pharmaceutical or medical devices industry, with a focus on Quality Control.
  • Extensive knowledge of regulatory expectations, including PICS, ICH, Singapore HSA, EMA, and US FDA.
  • Proficiencies in cGMP environment, sound technical knowledge of QC chemistry techniques (HPLC, UPLC, CE, etc.), strong interpersonal and communication skills in English, ability to work cross-functionally and meet timelines and objectives.