Senior QC Chemist Role at Thermo Fisher Scientific
We are seeking a highly skilled Senior Chemist to play a vital role in delivering world-class analytical solutions through outstanding expertise in biologic chemistry.
Key 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
To be successful in this role, you will need:
* A university degree or equivalent experience in chemistry, biochemistry, or life sciences.
* At least 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.
* 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.