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Nick Livings
Sales Director - Permanent Recruitment - Europe
We are seeking an experienced Analytical Scientist with expertise in physico-chemical techniques to join our Analytical Development & Testing team. This role involves the development, validation, and implementation of analytical methods to support our innovative pharmaceutical development projects.
Key Responsibilities:
Analytical Method Development: Develop and optimize robust analytical methods to support various development projects, focusing on techniques such as PSD, Rheology, DSC, Gel Permeation Chromatography, FT-IR, and Karl Fisher titration.
Equipment Management: Maintain and troubleshoot analytical instruments, ensuring their periodic performance and suitability. Responsible for equipment including Morphology G3, MS3000, Rheometer, and Differential Scanning Calorimetry.
Method Validation: Perform method check, pre-validation, and full validation in accordance with internal protocols and ICH guidelines. Ensure methods are fit for purpose and meet regulatory requirements.
SOP Review and Implementation: Review and update Standard Operating Procedures (SOPs) related to the use of analytical equipment and methods. Ensure compliance with GMP/GLP and ICH guidelines.
Data Analysis and Reporting: Compile, analyze, and process raw data to develop robust analytical methods. Document and report method development, validation, and transfer activities.
Technology Evaluation: Evaluate and implement new analytical technologies to enhance method development and testing capabilities.
Collaborative Projects: Support the transfer of analytical methods to internal and external partners, including Contract Development and Manufacturing Organizations (CDMOs).
Qualifications:
Education: Bachelor’s or Master’s degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field. PhD a plus
Experience: At least 3 years of relevant experience in a pharmaceutical development environment, with proficiency in Particle Size Determination by Laser Diffraction or Optical Microscopy, Rheology, and DSC techniques.
Technical Skills: Experience with Morphologi G3, Mastersizer 3000, Lab X, Empower 3 software, Gel Permeation Chromatography, KF, and FT-IR is highly desirable.
Knowledge: Familiarity with Quality by Design (QbD) principles in analytical method development and pre-validation. Understanding of GMP/GLP and ICH guidelines is a plus.
Soft Skills: Strong problem-solving abilities, attention to detail, and excellent communication skills. Ability to work effectively in a team-oriented environment.
Niveau hiérarchique
Manager
Type d’emploi
Temps plein
Fonction
Études/recherche et Sciences
Secteurs
Services de recherche, Recherche en biotechnologie et Fabrication de produits pharmaceutiques
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