Biologics MSAT Lead: Process & Scale-Up Leader

R&D Partners; Basel; Vor Ort; CHF 150.000 - 210.000; Vollzeit

Zusammenfassung

R&D Partners is seeking a senior leader to oversee biologics development and manufacturing, ensuring validated, compliant processes ready for inspection. You will drive process optimisation, yield improvements, and cost efficiency across commercial and clinical programs.

The role requires hands-on leadership of mammalian cell culture operations, cell banking, scale-down models, and external CMOs, with a focus on lifecycle management and regulatory support.

Qualifikationen

• Experience leading biologics development and manufacturing programs.
• Ability to drive process improvements and cost reductions.
• Experience with regulatory submissions and inspections.
• Experience coordinating with CMOs and external partners.

Aufgaben

• Lead technical aspects of biologics programs, ensuring compliance and readiness for inspections.
• Manage mammalian cell culture operations and implement new working cell banks.
• Oversee lifecycle management and projects to optimise processes and yields.
• Supervise tech transfer and scale-up with CMOs for clinical and commercial phases.
• Contribute to regulatory documentation and responses to authorities.
• Govern external manufacturing through studies, validations, and evaluations of CMOs.
• Drive continuous improvement to enhance process reliability and internal workflows.

Kenntnisse

Mammalian cell culture

Upstream ops

Cell banking

Scale-down model

Lifecycle management

Process optimization

Regulatory support

Cost-efficiency

Leadership

Cross-functional

Jobbeschreibung

R&D Partners is seeking a senior leader to oversee biologics development and manufacturing, ensuring validated, compliant processes ready for inspection. You will drive process optimisation, yield improvements, and cost efficiency across commercial and clinical programs.

The role requires hands-on leadership of mammalian cell culture operations, cell banking, scale-down models, and external CMOs, with a focus on lifecycle management and regulatory support.