GLP Project Manager in Analytical Chemistry

Il y a 4 mois

ProvenceAlpesCôte d'Azur, France ALBHADES Temps plein

About the Company

Albhades is a company specializing in microbiology and physico-chemistry, supporting the health product industries (pharmaceuticals, medical devices, cosmetics) as well as the chemical and food industries since 2001.

Its analytical capabilities, combined with a consulting service, provide a comprehensive solution for the development and validation of methods, process validation, and quality control of raw materials, finished products, and packaging. Albhades offers a complete analytical portfolio, including mineral chemistry, organic chemistry, NMR analysis, microbiology, cellular biology, mechanical testing, stability studies, and toxicology.

Location: Oraison, France

About the Role

As part of your role, you will be involved in several areas:

  • Organizing, planning, and monitoring the progress of extractables and leachables studies for drugs, medical devices, and various consumer products, in accordance with applicable standards (EP, USP, ISO, ICH, etc.).
  • Setting up and supervising Extractables/Leachables studies in the laboratory by defining their design according to applicable standards.
  • Defining and selecting effective equipment for conducting studies (HS-GC/MS, GC/MS, LC-UV/MS, LC/MS/MS, ICP/OES, ICP/MS, ILC).
  • Maintaining contact with clients regarding the studies being managed, playing an advisory role.
  • Writing and validating protocols, study plans, and reports concerning extractables/leachables.
  • Supervising other types of studies under GLP in analytical chemistry, as necessary.
  • Conducting a watch on developments in applicable regulations for the studies under your responsibility.

Responsibilities

  • Education: Degree in analytical chemistry (Master's or PhD).
  • Experience: 5 to 6 years of significant experience within a pharmaceutical industry, biotech, or CRO in a similar role.
  • Knowledge: Good understanding of GLP, pharmaceutical/medical device standards, and a mandatory mastery of chromatographic techniques and mass spectrometry.
  • Qualities: Curious, autonomous, with a desire to contribute your expertise to a long-term project.
  • Languages: Good level of English (Level B2).

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