Analytical Sciences & Technology Specialist

Genveon İlaç Sanayi ve Ticaret A.Ş.

We are looking for a Analytical Sciences & Technology Specialist that will be responsible from the following processes:

• Ensure full compliance with Health Authority requirements related to AS&T activities,
• Execute analytical activities in accordance with approved SOPs, GMP/GLP rules, and laboratory workflows,
• Perform assigned responsibilities accurately and timely in alignment with validated methods, procedures, and project timelines,
• Actively follow global analytical method development trends, current guidelines, and pharmacopeial requirements,
• Routinely review analytical monographs and proactively maintain compliance with current regulations, pharmacopeias, QM, QD, GOP, and SOP systems,
• Support the evaluation and implementation of new analytical technologies to sustain state-of-the-art methodologies for development and commercial products,
• Execute analytical method verification (AMVe), pre-validation and validation (AMV), and method transfer (AMT) studies,
• Ensure “right-first-time” execution for analytical testing and documentation,
• Prepare and support CTD sections related to analytical methods and updated testing monographs,
• Contribute to risk-based investigations, feasibility studies, and troubleshooting activities where required.

QUALIFICATIONS

• University degree in Chemistry, Chemical Engineering, Pharmacy, or related scientific disciplines,
• Minimum 1 year of experience in an analytical laboratory environment,
• Hands-on experience with common analytical techniques such as HPLC, GC, UV/Vis, LC-MS/MS is required,
• Experience in analytical method development, validation, and/or transfer (AMV / AME / AMT) activities,
• Experience or strong interest in advanced analytical techniques, including LC-MS/MS–based applications, method feasibility, validation, or transfer studies, preferably with Nitrosamine studies.
• Sound understanding of GxP requirements, data integrity principles, and regulatory expectations,
• Familiarity with mass spectrometry principles and impurity-related analytical approaches (e.g. trace-level analysis, sensitivity-driven methods) is considered a strong asset,
• Ability to work effectively in a fast-paced and evolving environment,
• Strong team-working skills with a solution-oriented and flexible mindset,
• Good analytical thinking capability and openness to continuous learning,
• Strong written and verbal communication skills,
• Proficiency in MS Office applications,
• Good command of English,
• No military obligation for male candidates.