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Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Scientist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeSuzhou, Jiangsu, ChinaNo salary listed

About the Job

Requirements

  • A bachelor's degree or equivalent and relevant formal academic or vocational qualification is required.
  • Previous experience comparable to 2+ years is required.
  • Strong background and hands-on experience in large-molecule bioanalysis and ligand-binding immunoassays is required.
  • Hands-on experience with electrochemiluminescence-based assays and MSD instruments is required.
  • Experience in pharmacokinetic and anti-drug antibody assay sample analysis, data processing, and data review is required.
  • Demonstrated experience working in a Good Laboratory Practice-regulated bioanalytical laboratory, with understanding of applicable standard operating procedures, data integrity, and regulatory requirements is required.
  • Ability to independently execute analytical methods and perform assay troubleshooting and investigation is required.
  • Strong data interpretation, technical writing, communication, and problem-solving skills are required.
  • Proficiency in Microsoft Excel and Word is required.
  • Ability to manage multiple tasks and work independently and collaboratively within a team is required.
  • Ability to work upright or stationary for 6–8 hours per day and perform repetitive hand movements to operate laboratory equipment is required.
  • Ability to lift and carry up to 15–20 pounds is required.
  • Personal protective equipment, including protective eyewear, garments, and gloves, is required.

Responsibilities

  • Perform complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in formulations and biological matrices for stability and analytical testing.
  • Work with multiple functional groups to meet business needs.
  • Plan and organize work with periodic supervision.
  • Set up and maintain analytical instrumentation.
  • Train in the routine operation, maintenance, and theory of analytical instrumentation, standard operating procedures, and regulatory procedures and guidelines.
  • Ensure quality-assurance findings are addressed appropriately.
  • Provide assistance and training to other team members.
  • Troubleshoot extraction and instrumentation problems independently or with assistance.
  • Communicate project status to the project leader.
  • Perform work assignments accurately, in a timely manner, and safely.
  • Review, interpret, and analyze data for technical quality and compliance with protocols, methods, standard operating procedures, client criteria, and Good Manufacturing Practices or Good Laboratory Practices; conduct self and peer review of data for accuracy and compliance with reporting requirements before submission to quality assurance and issuance to customers.
  • Work in a laboratory and/or clinical environment, with potential exposure to biological fluids and infectious organisms, and occasional exposure to other listed hazards.
  • Occasionally drive to site locations and travel domestically.
  • Use a variety of in-house and off-the-shelf computer software and communicate and obtain information through interactions with diverse groups.

Desired Qualifications

  • Experience with automated liquid-handling systems such as MD384 and Hamilton is preferred.
  • Knowledge of bioanalytical method development, validation, and sample analysis is preferred.

About the Company

Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.

Company size
10,001+
Company stage
IPO
Headquarters
Waltham, MA
Founded
1956

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