Senior QC Specialist ( 1 Year Novartis Contract)

Novartis AG

Infos sur l'emploi

Date de publication :30 juin 2025
Taux d'activité :100%
Lieu de travail :Basel (City)

Résumé de l'emploi

Nous recherchons un expert analytique motivé en production biopharmaceutique. Une opportunité passionnante dans un environnement collaboratif et innovant.

Tâches

Coordonner et valider les tests de contrôle qualité sur les substances biologiques.
Collaborer avec les équipes projet pour garantir la conformité réglementaire.
Diriger les activités de validation et de transfert des procédures analytiques.

Compétences

MSc ou PhD en biotechnologie, chimie analytique ou domaine connexe, +3 ans d'expérience.
Compétences en gestion des tests de contrôle qualité et en équipement de laboratoire.
Capacité à travailler en équipe et à faire face à l'ambiguïté.

Est-ce utile ?

Summary

We are seeking a motivated analytical expert for biopharmaceutical production within the framework QC testing for in-process controls, raw materials and drug substance. The role involves leading current and future analytical control strategies, focusing on release testing, method validation, and method transfer for new biopharmaceutical entities.

About the Role

Major accountabilities:

Coordinate, review and release of quality control tests on biologics drug substances (Physicochemical testing, e.g. HPLC, Capillary Electrophoresis, UV) ensuring compliance with regulatory requirements

Maintain excellent planning and collaboration with project team members (e.g. laboratory analysts, production specialists, manufacturing science and technology, quality assurance, regulatory CMC, project leaders and colleagues)

Participate in or create, review, approve registration documents

Manage analytical weak points of assigned pipeline

Perform deviations/OOX investigation

Support troubleshooting for testing procedures and make recommendations for improvements, with a focus on HPLC and Capillary Electrophoresis, Bioburden and Endotoxin

Lead validation and transfer activities for analytical procedures

Lead qualification, maintenance, and calibration of instruments

Lead LabOpex Projects

Key performance indicators:

Timely completion of key deliverables

Prompt reporting of missed deadlines and aim for shortest possible lead times

Consistently follow the GMP and GSU guidelines, and SOPs, ensuring no critical irregularities continuous readiness for inspection

Proactively identify and implement cost-reducing optimizations

Minimum Requirements:

MSc or PhD in biotechnology, analytical chemistry or related field, +3 years industry experience

Good IT skills (MS Office) and laboratory software like LIMS, Chromeleon, Empower are an advantage

Reliability, flexibility, resilience, and strong teamwork skills

Skills:

Continuous learning

Dealing with ambiguity

Decision making

Industry standards

Laboratory equipment

Laboratory excellence

Quality Control (QC) testing

Quality Control sampling

Self awareness

Technological expertise

Languages :

Fluent in English and German (spoken and written)

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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