Clinical Laboratory Scientist Specialist II

1 month ago


Nanjing, Jiangsu, China Thermo Fisher Scientific Full time
Key Responsibilities

As a Clinical Laboratory Scientist Specialist II at Thermo Fisher Scientific, you will be responsible for performing complex laboratory analysis of pharmaceutical products, utilizing analytical instrumentation, and calculating and analyzing data in adherence with PPD SOPs and industry standards.

Key Responsibilities:
  • Independently perform method validations, method transfers, and analytical testing of pharmaceutical and biopharmaceutical compounds in various formulations and delivery systems.
  • Design and execute experiments with minimal supervision, understanding and conforming to methods and protocols applicable to assigned tasks.
  • Prepare study protocols, project status reports, final study reports, and other project-related technical documents.
  • Communicate data and technical issues to clients and respond to client needs and questions.
  • Mentor, train, and coordinate laboratory activities of other team members and assist in troubleshooting instrument and analytical problems.
  • Assist with quality systems and new equipment.
  • Assist in designing method validation or method transfer protocols and establish project timelines.
  • Review, interpret, and analyze data for technical, quality, and compliance to protocols, methods, SOPs, client criteria, and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
Requirements

To be successful in this role, you will need:

  • A Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
  • Solid understanding and knowledge of general chemistry and separation science.
  • Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements, and FDA guidance.
  • Ability to utilize Microsoft Excel and Word to perform tasks.
  • Proficiency on technical operating systems.
  • Proven problem-solving and troubleshooting abilities.
  • Effective oral and written communication skills.
  • Proven ability in technical writing skills.
  • Time management and project management skills.
  • Ability to work in a collaborative work environment with a team.
What We Offer

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. We value diverse experiences, backgrounds, and perspectives and are committed to accelerating research, solving complex scientific challenges, driving technological innovation, and supporting patients in need.



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