Analytical Development Scientist [Ireland]


 

Job Description

About the site:
This role is based at our Cork, Ireland API site.
Operating for over 40 years, the Cork site is proud to manufacture and supply Active Pharmaceutical Ingredients (API) to our customers for use in clinical trials and approved medicines for commercial supply - medicines to treat Cancer, Parkinson’s Disease, Depression, HIV, Congestive Heart Failure, Diabetes and Respiratory diseases, along with raw material for consumer healthcare products!
Job Summary:
The Analytical Chemist will function as a key member of the Process Development Service Team. You’ll be responsible for providing analytical expertise and technical support for all phases of drug development. This will include supporting the analytical aspects of route scouting, route development, proof of concept of new and existing manufacturing routes for APIs. You will focus on the development of new or existing analytical methods and their subsequent validation/qualification and transfer to the clients. You’ll be able to work as part of a team, across functions and on your own initiative and be able to review current practices with the target of using Practical Process Improvements (PPI) to identify improvements and cost saving to the business.

What will you do?
  • Provide technical expertise and analytical support for the introduction of new products to the Cork site, including method development, validation/qualification and transfer of methods to clients as required.
  • Lead in troubleshooting analytical technical challenges during the development, pre-validation validation/qualification and transfer of methods.
Plan, execute and evaluate fate of impurities studies in collaboration with colleagues and client through interpretation of analytical data and adhering to current and emerging regulatory strategies (quality by design, GMP, ICH’s guidelines) for API.
  • Complete analytical data collection, interpretation and characterization of compounds while ensuring proper documentation of experimental data is adhered to.
  • Support innovative development of new analytical methods as well as improvement and optimization of current methods.
  • Provide lead analytical support to development projects in the laboratory by supporting route scouting, route development, proof of concept and process proven acceptable range studies.
  • Author or contribute to regulatory submissions and patents as required.
  • Communicate regularly with the clients, providing updates on projects progress, hosting clients visits, addressing technical queries and delivering client project requirements to the defined timelines.
  • Develop/Expand scientific, technical knowledge by reading the peer reviewed scientific literature, attending scientific conferences and via relevant training.
  • Ensure the delivery of projects in the required timeframe and ensure that the site’s technical, quality and safety metrics are all achieved.
Education / Experience Required:
  • Relevant qualification such as BSc; masters or PhD in relevant scientific subject area with a significant experience in industry or academia.
  • Experience in analytical method development, characterization and validation.
  • A subject matter expert with HPLC, UHPLC, GC, LC/MS, GC/Headspace, GC/MS, UV, IR, KF, ion chromatography, ICP.
Knowledge, Skills, Abilities:
  • Demonstrated ability to think critically and innovatively combined with willingness to challenge.
  • You will have great organizational skills and proven ability of troubleshooting to rapidly respond to technical challenges. Embrace and participate in PPI (Practical Process Improvement) initiatives to identify improvements and cost saving to the business.
  • Excellent technical writing skills and oral communication with the ability to work with cross functional teams with collaborative communication skills to engage with employees and clients at all levels.
  • Knowledge and experience within a pharmaceutical manufacturing and chemical development environment and an understanding of the drug development process is desirable.
  • Demonstrated core laboratory skills and expertise in various wet chemistry and analytical techniques such as spectroscopy and chromatography techniques, with an excellent understanding of the relevance of the data generated.
What’s in it for you?
  • Competitive base salary
  • Annual bonus
  • 25 days holiday + Good Friday + Christmas Eve
  • Contributory Pension
  • Private medical insurance
  • Free onsite parking
  • Various other optional, flexible benefits to suit your needs!
About us
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.


 

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