Chemist I

Thermo Fisher Scientific Inc.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A global life sciences company in Singapore is seeking a Chemist I to support quality control operations and ensure regulatory compliance. The ideal candidate will have a degree in chemistry or life sciences, with 2-3 years of relevant experience in the pharmaceutical sector. Responsibilities include analyzing products, equipment qualification, and participating in audits. The position may require shift work and adherence to strict safety standards.

Qualifications

• 2-3 years of experience in pharmaceutical or medical devices industry, focusing on Quality Control.
• Knowledge of regulatory expectations (PICS, ICH, Singapore HSA, EMA, US FDA).
• Knowledge and exposure to cGMP environment.

Responsibilities

• Support new equipment qualification and lab setup.
• Review analytical and laboratory data for accuracy.
• Act as a Subject Matter Expert during audits.

Skills

QC chemistry techniques (HPLC, UPLC, CE)

Interpersonal and communication skills

Ability to work cross-functionally

Education

University degree in chemistry, biochemistry, or life sciences

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

Position Summary

As a Chemist I, you will play a vital role in delivering world-class analytical solutions through outstanding expertise in biologic chemistry. Your work will significantly impact 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.

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.
• Communicate effectively with cross-functional teams and participate in problem-solving activities.
• Act as a Subject Matter Expert during audits and inspections.
• Undertake internal audits and support continuous improvement initiatives.
• Promote a culture of quality and adherence to cGMP, EHS, and 5S standards.
• Be prepared to support shift work if needed.

Minimum Requirements/Qualifications

Education:

• University degree or equivalent experience in chemistry, biochemistry, or life sciences.

Experience:

• At least 2-3 years of proven experience in the pharmaceutical or medical devices industry, with a focus on Quality Control.
• Knowledge of regulatory expectations including PICS, ICH, Singapore HSA, EMA, and US FDA.

Proficiencies:

• Knowledge and exposure to 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.
• Experience with Health Agency/internal audits.