Pavel Parkhomyuk

Experience

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  Ben-Gurion University of the Negev

  Sept 2000 - Feb 2004

  Analytical lab instructor

  # teaching of the concepts to be developed through carrying out laboratory experiments in analytical chemistry and, in particular, for the teaching of analytical chemistry laboratory techniques and procedures;# maintenance of safe laboratory environments by ensuring that the students understand all safety aspects associated with employed chemicals and equipment;# testing of solutions and preparations to ensure that they function correctly in the specific experiments for which they are intended;# updating and improvement of all experiments, the development of new experiments; # revision and or rewriting of laboratory manuals;# grading of student laboratory reports and recording of grades for individual experiments. Show less

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  Teva Pharmaceuticals

  Feb 2004 - Sept 2018

  ANALYTICAL R&D TEAM LEADER, Teva API Division

  # Coordination of API analytical development, ensuring delivery of robust, reliable validated test methods, specifications and regulatory documents;# Managing the development teams comprised of up to 7 analytical chemists;# Evaluation of compendia specifications and methodology;# Authoring and reviewing method development reports and related documents;# Characterization of reference and working standards;# Management of analytical methods transfer to routine manufacture (in house or sub contractors);# Management of API stability programs; # Providing customer service;# Participation in determination of regulatory strategies in support of ANDA filings;Coordination of regulatory responses to deficiency letters;# Ensuring that the group and the lab complies with cGMP, SOP, FDA regulations, ICH guidelines, OSHA and safety procedures;# Participation in authorities and customers audits. Show less

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  TAPI - Teva Active Pharmaceutical Ingredients

  Sept 2018 - now

  Overall responsibility on the post-DMF API product lifecycle, including but not limited to: locating potential gaps in regulatory submissions, performing validations, answering deficiency letters, providing customer support, accompanying authorities inspections etc.

  • Synthetic Peptides Science, Technology and CMC RND Manager

    Nov 2021 - now

  • Head of DMF-to-Launch Group

    Sept 2018 - Nov 2021