Research and Development Scientist

• Conduct literature review and assist in the development of new services and projects
• Participate in the development and validation of analytical methods and improvement of existing ones to support all stages of drug development from drug substance characterization through formulations and process development
• Perform sample analysis, method development
• Prepare and review analytical data, technical reports and analytical methods in support of and for inclusion in the regulatory submissions. Prepare and review study & method validation protocols.
• Compile, maintain, review and interpret analytical and statistical data; assist with generating high quality technical documents required for method validation
• Prepare high quality technical documents required for analytical purposes
• Perform the drafting of scientific texts and study reports
• Identify, document and report analytical issues
• Maintain and follow all laboratory systems
• Adhere to safety and housekeeping requirements
• Manage deliverables and ensure that necessary supplies such as standards, reagents, columns, impurities are available on time for projects
• Prepare SOPs, as required

Απαραίτητα Προσόντα:

• BSc in Chemistry or Biochemistry
• MSc Degree in Chemistry with specialization in Analytical Chemistry / Pharmaceutical Analysis or relevant field.
• PhD in a relevant field will be considered an asset
• At least 2 years of experience in the Pharmaceutical Industry within the field of pharmaceutical analysis, Quality Control, R&D
• Experience in a GLP / GMP oriented laboratory
• Experience in method development
• Excellent communication in English language (writing & speaking)
• Knowledge of cGMP, USP/NF, ICH, DEA, EU and FDA guidelines and regulations will be considered an asset
• Competency in analytical methods development and validation according to ICH guidelines
• Strong problem-solving, troubleshooting skills
• Demonstrated ability to work on multiple projects and meet timelines
  

Παροχές: