• 2350965
  • (Reference :33)
  • Analytical Development Analyst


  • As soon as possible
  • To be discussed
  • Under the responsability of the Analytical Development Supervisor, you will manager various development projects, validation and/or transfer of analytical methods in R&D, within a Canadian or American regulatory context.

    - Conduct laboratory analyses using analytical methods, in accordance with GMPs;
    - Conduct analyses required by R&D during process validation;
    - Develop and validate analytical methods for cleaning residues (cleaning validation);
    - Validate and transfer analytical methods according to protocols;
    - Prepare protocols and validation reports;
    - Complete documentation related to testing (laboratory notebook, records, etc.).


    - B.Sc.or M.Sc. in chemistry or biochemistry;
    - At least five (5) years of experience in developing, validating and transferring analytical methods;
    - In-depth knowledge of using HPLC, UPLC and GC equipment;
    - Very good knowledge of ICH, FDA, USP and Health Canada guidelines regarding method validation or transfer and of regulatory submission requirements in order to prepare documents accordingly (ANDA, CBE 30);
    - Proficiency in using Microsoft Office (Word, Excel, PowerPoint) and Empower 3;
    - Keen sense of observation, meticulousness and professionalism;
    - Bilingual spoken and written.

Company description

Confab Laboratories is part of Mylan Pharmaceuticals ULC, one of the largest pharmaceutical companies in the world with over 35,000 employees across 165 countries.
Confab specializes in the development and manufacturing of non-sterile pharmaceutical drugs (CDMO). The plant, located on the south shore of Montreal, is growing with major expansion investments underway to support an increasing volume of R&D projects as well as pioneering new dosage forms.
The company complies with both Canadian and US regulatory requirements. To know more about Confab Laboratories please visit the website at http://www.confab.com/

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