Senior QC Specialist ( 1 Year Novartis Contract)
Basel (City)
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
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
- GMP
- 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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network(link is external)
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
