Senior MSAT Biologics Lead for Process Transfer

Sobi - Swedish Orphan Biovitrum AB (publ); Basel; Vor Ort; CHF 150.000 - 220.000; Vollzeit

Benefits dieser Stelle

Work-life balance

Collaborative culture

Professional growth

Diversity & Inclusion

Competitive compensation

Impactful work

Zusammenfassung

Sobi in Basel is seeking a Technical Lead for DS Biologics manufacturing within SAT. You will drive technical excellence, regulatory compliance and lifecycle improvements across internal and external manufacturing networks.

Lead process validation, technology transfers, and MSAT projects while coordinating with regulatory teams to support product launches and market expansion. Fluency in English and willingness to travel up to 30% are required.

Qualifikationen

• 10+ years of DS Biologics manufacturing for commercial use.
• Strong upstream manufacturing including cell banking and mammalian culture.
• Experience with regulatory guidelines and authorities' communication.
• Fluent in English and able to travel up to 30%.

Aufgaben

• Act as SME for DS Biologics manufacturing and validation ownership.
• Lead MSAT projects for process and cost improvements within lifecycle management.
• Coordinate cross-functional activities for tech transfers and new manufacturing capabilities.
• Oversee external manufacturers, process changes, deviations, CAPAs and documentation.
• Support registration files, variations and health authority responses.

Kenntnisse

Upstream Biologics Manufacturing

Regulatory Experience

Cross-Functional Leadership

English Proficiency

Process Validation

Ausbildung

University degree in Biology/Biotechnology/Pharmaceuticals

Jobbeschreibung

Sobi in Basel is seeking a Technical Lead for DS Biologics manufacturing within SAT. You will drive technical excellence, regulatory compliance and lifecycle improvements across internal and external manufacturing networks.

Lead process validation, technology transfers, and MSAT projects while coordinating with regulatory teams to support product launches and market expansion. Fluency in English and willingness to travel up to 30% are required.