Chemist I
Chemist I
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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 materialsJob 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.
Employment Type
Full-Time
