Senior/Regular Analytical Specialist - Biologics Analysis

1000scholars; Kraków; Sur place; PLN 180 000 - 260 000; Plein temps

Résumé du poste

Selvita in Kraków, Poland, seeks a Senior Analytical Specialist to lead LC-MS-based characterization of biologics and related analyses. You will own analytical development, method transfer, and troubleshooting while ensuring quality and timely delivery within cross-functional teams.

The role emphasizes state-of-the-art LC-MS workflows, RP-HPLC, SEC-HPLC, and IEX-HPLC, with opportunities to employ DLS, DSC, MALS, and other orthogonal techniques.

Qualifications

• MSc in life sciences or analytical chemistry, biochemistry, biotechnology, or pharmacy.
• PhD is an advantage.
• Hands-on LC-MS-based characterization experience with biologics.
• Experience in analytical method development, validation, and data interpretation.
• Knowledge of ICH guidelines and GxP environments is a plus.

Responsabilités

• Take ownership of projects, ensuring scientific quality, timely delivery, and proper documentation.
• Plan and execute analytical activities for biologics characterization and development projects.
• Develop, 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.

Connaissances

LC-MS

RP-HPLC

SEC-HPLC

IEX-HPLC

Protein characterization

Sample preparation

Analytical method development

Method validation

Data interpretation

Troubleshooting

Formation

MSc in life sciences or related field

PhD preferred

Outils

LC-MS instrumentation

DLS

DSC

MALS

Description du poste

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, high-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.