Research and Development Analyst

Μηχανικοί ΑΕΙ / ΤΕΙ - Επιστήμες

ΑΘΗΝΑ - ΑΤΤΙΚΗ

Πλήρης απασχόληση

Γενικό Λύκειο

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