Senior/Regular Analytical Specialist - Biologics Analysis

Senior/Regular Analytical Specialist - Biologics Analysis

Selvita

Kraków, Poland

As part of our continued growth and expansion, we are seeking an experienced and scientifically driven Senior Analytical Specialist to join our Analytical Team, contributing to comprehensive characterization and development activities for biological drugs.

This role is aimed at scientists with solid hands-on experience in LC-MS-based characterization of biologics, who are ready to take ownership of analytical activities and contribute to the successful delivery of complex projects. The position offers an opportunity to work primarily with advanced LC-MS workflows for the characterization of therapeutic proteins, complemented by chromatographic and orthogonal analytical techniques, including RP-HPLC, SEC-HPLC, IEX-HPLC, DLS, DSC, UV, MALS, CE-SDS, and cIEF.

Key Responsibilities

• Take ownership of projects, ensuring scientific quality, timely delivery, and proper documentation.
• Plan and execute analytical activities for biologics characterization and development projects.
• Develop, optimize, transfer, validate, and perform analytical methods, including LC-MS, SEC-HPLC, IEX-HPLC, and RP-HPLC, and related techniques.
• Conduct characterization, comparability, stability, and forced degradation studies in line with relevant guidelines and quality standards.
• Prepare and review protocols, reports, and technical documentation.
• Operate, maintain, and troubleshoot LC-MS and chromatographic systems.
• Collaborate with multidisciplinary teams and communicate analytical results and scientific conclusions to clients.

Your Background

• MSc in life sciences, analytical chemistry, biochemistry, biotechnology, pharmacy, or a related field; PhD is an advantage.
• Experience in analytical development and biologics characterization.
• Strong hands-on expertise in LC-MS, RP-HPLC, SEC-HPLC, IEX-HPLC, protein characterization, and sample preparation.
• Experience in analytical method development, optimization, validation, and data interpretation.
• Good understanding of protein structure and characterization, including PTMs, higher-order structure, purity, stability, aggregation, and degradation.
• Ability to troubleshoot analytical methods and instrumentation independently.
• Experience with comparability, stability, or forced degradation studies and complementary techniques (e.g., DLS, DSC, MALS) is an advantage.
• Knowledge of ICH guidelines and GxP/GLP environments is a plus.
• Fluent English and strong analytical, organizational, communication, and teamwork skills.