Chemist II

Thermo Fisher Scientific Inc.; Singapore; On-site; SGD 60,000 - 85,000; Full time

Job summary

A leading company in the analytical solutions field is seeking a Chemist II. In this role, you will ensure quality control of biologic chemistry products through method qualifications and validations, while working within a cGMP environment. Candidates should possess a degree in a relevant field and have 5-7 years of experience in quality control within the pharmaceutical industry. Strong communication skills and the ability to train others will be essential.

Qualifications

• 5-7 years of experience in the pharmaceutical or medical devices industry.
• Knowledge of regulatory expectations (HSA, EMA, FDA).
• Experience with Health Agency/internal audits.

Responsibilities

• Support new equipment qualification and lab setup.
• Analyze incoming goods under cGMP conditions for QC release.
• Lead lab investigations and ensure timely closure in quality management systems.

Skills

Knowledge of QC chemistry techniques (HPLC, UPLC, CE)

Strong interpersonal skills

Communication skills in English

Education

University degree in chemistry, biochemistry, or life sciences

Job description

Work Schedule

Other

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Position Summary

As a Chemist II, 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 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:

• 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.