Research and Development Scientist wanted by Viofar in Athens.
Main duties and Responsibilities
- 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
Requirements - The ideal candidate should have:
- 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