Analytical Chemist

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.