MSAT Technical Lead

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

Could your expertise in biologics development and manufacturing help optimise processes, improve yields, and shape the future of life-changing therapies?

R&D Partners is seeking a skilled professional to provide technical leadership in biologics development and manufacturing. In this role, you will oversee commercial and clinical programs, ensuring processes are validated, compliant, and ready for inspection. You will play a key role in optimizing processes, improving yields, and driving cost efficiency while collaborating with external manufacturing partners and regulatory bodies.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Lead technical aspects of biologics programs, ensuring compliance and readiness for inspections.
• Manage mammalian cell culture operations, including cell banking, implementing new working cell banks, and qualifying scale-down models.
• Oversee lifecycle management and execute projects to optimise processes, improve yields, and reduce costs.
• Supervise technology transfer and scale-up activities with external manufacturing partners for clinical and commercial phases.
• Contribute to regulatory documentation, including annual product reviews, registration files, variations, and responses to regulatory queries.
• Govern external manufacturing by supervising technical studies, qualifications, validations, and evaluations of contract manufacturing organizations (CMOs).
• Drive continuous improvement initiatives to enhance process reliability, robustness, and internal workflows.

Key Skills and Requirements:

• Strong expertise in mammalian cell culture and upstream operations.
• Experience with cell banking, scale-down model qualification, and new working cell bank implementation.
• Knowledge of lifecycle management, process optimisation, and cost-efficiency strategies.
• Familiarity with technology transfer, scale-up processes, and external manufacturing oversight.
• Ability to contribute to regulatory documentation and respond to authority queries.
• Proven ability to lead continuous improvement initiatives and enhance business processes.
• Strong organisational, communication, and problem-solving skills.

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