Sobi
TechOps Product Lead, Director(m/w/x)
Vollzeit
mit Homeoffice
Keine Angabe
Basel
SO
Sobi24 Tage
Senior Process Manager MSAT(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
Basel
Nejo KI-Zusammenfassung
In this role, you will ensure the compliant and sustainable manufacturing of clinical and commercial products, leading projects that enhance processes and reduce costs while collaborating with internal and external partners.
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Anforderungen
- •University degree in Chemistry, Biology, Biotechnology, Pharmacy, or related field
- •At least 5 years of experience in development and manufacturing of drug products for clinical and commercial use
- •Deep scientific and technical expertise in CMC development and aseptic drug product manufacturing
- •Recognition as an expert in aseptic drug product manufacturing
- •Experience working in cross-functional teams, with multitasking, prioritization, and decision-making skills
- •Strong knowledge of regulatory guidelines, experience in communication with regulatory authorities, and proficiency in preparing regulatory documentation
- •Fluency in English with excellent oral and written communication skills
Bachelor-Abschluss
Berufserfahrung
5 Jahre
Deine Aufgaben
- •Serve as the subject matter expert for drug product manufacturing and validation
- •Lead MSAT projects focused on process and cost improvements
- •Participate in internal and external manufacturing activities
- •Manage process changes, major deviations, risk assessments, and CAPAs
- •Issue, review, and approve internal and external SOPs and manufacturing instructions
- •Oversee setup, execution, and documentation of technical studies, qualifications, and validations
- •Contribute to the development and review of new product specifications and stability programs
- •Write and review sections of APR/PQR, registration files, variations, and market expansion documents
- •Support evaluation and onboarding of new drug product contract manufacturers
- •Develop supply and quality agreements with contract manufacturers
- •Lead technical aspects of product transfers and scale-up activities
- •Oversee validations and manufacturing at external partners for clinical and commercial projects
- •Stay informed about advancements in biopharmaceutical manufacturing technology
- •Introduce innovations that drive process improvement, cost reduction, or yield enhancement
Sprachen
Englisch – verhandlungssicher
Deine Vorteile
Attraktive Vergütung
- •Competitive compensation
Familienfreundlichkeit
- •Emphasis on work/life balance
Lockere Unternehmenskultur
- •Collaborative and team-oriented environment
Karriere- und Weiterentwicklung
- •Opportunities for professional growth
Sonstige Vorteile
- •Diversity and Inclusion
Sinnstiftende Arbeit
- •Positive impact on ultra-rare disease patients
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. 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.
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