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Job ID :
64969BR
Location :
Netherlands - Tilburg
:
Job Description
The Analytical Development (AD) Chemist is responsible for conducting analytical work within the Analytical Development Department R&D. You are conducting analytical work for analytical R&D projects according GMP/GLP and ICH guidelines by:
  • Collecting samples, label packs, put/pull samples in stability chambers following the protocols;
  • Conducting stability studies according ICH guidelines;
  • Conducting physical and chemical analysis with HPLC, GC, UV/VIS, FTIR, Karl-Fisher, Dissolution and Disintegration instruments;
  • Developing and validation of analytical methods;
  • Transferring analytical methods to QC or to other Patheon companies;
  • Conducting cleaning validations and conduct analysis of cleaning validation samples;
  • Trouble shooting at QC lab for release of new nutritional and pharmaceutical products;
  • Assisting the QA validation department with performing cleaning validation programs;
  • Overseeing and coordinating activities at contract Laboratories;
  • Coordinating stock for chemicals/consumables;
  • Writing analytical activities in lab note books;
  • Conforming GMP/GLP guidelines;
  • Performing double checks of all analytical results;
  • Writing analytical stability protocols and reports;
  • Writing analytical validation protocols and reports;
  • Establishing, revising and enforcing laboratory policies and procedures, which are relevant for the analytical R&D department;
  • Keeping up to date with current regulatory requirements (ICH/FDA) guidelines and GLP/GMP guidelines) and pharmacopoeia requirements (EP/USP) with respect to method validation and stability studies;
  • Double checking of analytical test result in lab note books and stability data sheets;
  • Performing investigations and writing failure report for out of specification (OOS) test results and document findings;
  • Exchanging information within R&D, QC, QA and Operations (internally meetings/e-mails);
  • Keeping up to date with development in Analytical Technologies.

Qualifications
  • Education in chemistry or Analytical chemistry HBO+.
  • A minimum of 5 years’ experience not only in pharmaceutical, but method development and validation as well.
  • Good skills to conduct accurate chemical analysis with analytical equipment.
  • Strong technical knowledge in the analytical chemistry.
  • Excellent reporting capability.
  • A good working knowledge of oral and written English.
  • Current knowledge of GLP/GMP and ICH/FDA requirements and Pharmacopeia (EP/USP) requirements for analytical development and stability studies.



Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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