Novartis Pharma AG
Analytical Project Lead(m/w/x)
Vollzeitmit HomeofficeSenior
Basel
ab CHF 126.000 - 234.000 / Jahr
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
SOSobi
MSAT Technical Lead - Drug Substance - Biologics(m/w/x)
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Subject matter expert for biologics drug substance manufacturing, focusing on upstream processes and cell banking. University degree in life sciences required. Collaborative environment, opportunities for professional growth.
Deine Match-Analyse
von deinem Karriere-Agenten
Warum dieser Job zu dir passt
Mögliche Lücken
Tipps für deine Bewerbung
Anforderungen
- University education in Biology, Biotechnology, Pharmacy or similar
- Strong background in Upstream Manufacturing (including Cell banking and new working cell bank implementation)
- Mammalian Cell culture mainly and bacterial fermentation a plus
- Strong understanding of scale down models and their qualification a plus
- Scientific and technical background of CMC development, product launch is a plus
- Experience of regulatory guidelines and authorities’ communication
- Experience working in cross-functional teams
- Ability to multitask, prioritize, and make effective decisions
- Ability to thrive in new, unstructured environments
- Ability to influence without authority
- Ability to act independently and take initiative
- Good communication skills (oral/written and listening)
- Fluent English
Aufgaben
- Ensure technical excellence and regulatory compliance
- Drive cross-functional collaboration for product launches
- Manage lifecycle of products and technology transfers
- Implement innovative methodologies
- Serve as subject matter expert for DS Biologics manufacturing
- Own DS Biologics validation for Sobi products
- Lead MSAT projects for process and cost improvement
- Participate in and lead manufacturing process changes
- Manage major and critical deviations
- Conduct risk assessments and CAPAs
- Issue, review, and approve internal and external SOPs
- Supervise setup, execution, and documentation of technical studies
- Write and review applicable sections of APR/PQR
- Contribute to registration files, variations, and market expansion
- Respond to Health Authority requests and questions
- Evaluate new DS Biologics contract manufacturers
- Develop supply and quality agreements
- Lead process components of product transfer
- Oversee scale-up activities and validations
- Supervise manufacturing of DS Biologics processes
- Stay informed about pharmaceutical manufacturing advancements
- Introduce new technologies for process innovation
- Represent SAT in product governance teams
- Coordinate oversight and escalation of DS, DP, and Analytical projects
- Support continuous improvement of internal business processes
Berufserfahrung
10 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Englisch – fließend
Benefits
Familienfreundlichkeit
- Work/life balance
Lockere Unternehmenskultur
- Collaborative environment
Karriere- und Weiterentwicklung
- Opportunities for professional growth
Sonstige Vorteile
- Diversity and Inclusion
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Sobi erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei SobiÜber das Unternehmen
SO
PharmaceuticalsBasel
The company is a specialized biopharmaceutical company dedicated to rare diseases and committed to developing innovative therapies.
Wie gut ist dein Lebenslauf?
Nejo bewertet ihn, und bringt ihn danach gemeinsam mit dir in Bestform.
Du hast noch keinen Lebenslauf?
Noch nicht perfekt?
- Novartis Pharma AGSenior Quality Control Specialist(m/w/x)Vollzeitmit HomeofficeSeniorBaselab CHF 85.400 - 158.600 / Jahr
- Novartis Pharma AGSenior Quality Control Specialist(m/w/x)Vollzeitmit HomeofficeSeniorBaselab CHF 85.400 - 158.600 / Jahr
- CHEPLAPHARM Arzneimittel GmbHSenior Portfolio Owner Quality(m/w/x)Vollzeitmit HomeofficeSeniorGreifswald, Berlin, Binningen
- CHEPLAPHARM Arzneimittel GmbHHead of Change & Deviation Management(m/w/x)Vollzeitmit HomeofficeSeniorGreifswald, Berlin, Binningen