AD chemist
Thermo Fisher Scientific
34 dagen geleden

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.
  • Solliciteren
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