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Pharmaceutical Analysis Expert

2 weeks ago

Athlone, County Westmeath, Ireland Thermo Fisher Scientific Inc. Full time

Our Team

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At Thermo Fisher Scientific Inc., we take pride in being a global leader in serving science.

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Our dedicated team of scientists, industry thought-leaders and therapeutic experts work together to accelerate research, solve complex scientific challenges and drive technological innovation.

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What We Do

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We enable our customers to make the world healthier, cleaner and safer through our PPD clinical research portfolio.

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With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research, our work spans laboratory, digital and decentralized clinical trial services.

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Your Role

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As a Scientist III, you will be responsible for performing complex laboratory analysis of pharmaceutical products and proficiently using analytical instrumentation.

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You will routinely act as the project leader on multiple projects, interacting with clients, reviewing and evaluating data, writing reports and protocols.

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Responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members.

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A Typical Day

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  • Independently performs method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems.\
  • Understands and conforms to methods and protocols applicable to assigned tasks. Designs and drives experiments with minimal supervision.\
  • Prepares study protocols, project status reports, final study reports and other project-related technical documents.\
  • Communicates data and technical issues to the client and responds to client needs and questions.\
  • Mentors, trains and coordinates laboratory activities of other team members and assists in troubleshooting instrument and analytical problems.\
  • Assists with quality systems and new equipment.\
  • Assists in designing method validation or method transfer protocols and establish project timelines.\
  • Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).\
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Skills and Qualifications

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  • 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 apply 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.\
  • Ability to train junior staff.\
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Benefits and Perks

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We offer a range of benefits and perks that reflect our commitment to our employees' well-being and success.

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We value diversity and inclusion in the workplace and strive to create an environment that is welcoming and inclusive for all employees.