Biotech GMP Upstream Operations Specialist

MSD; Werthenstein; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

MSD is seeking a Specialist Upstream Operations in Switzerland to support GMP manufacturing of early-phase biologics. The role requires full-time site presence at Schachen, Zurich area, and involves setting up upstream operations, ensuring GMP compliance, and documentation throughout process transfers and CAPA investigations.

You will mentor junior staff, engage in continuous improvement, and collaborate with QA and other stakeholders.

Qualifikationen

• 2–5 years’ experience in pharma/biotech industry.
• Minimum 2 years in GMP biologics manufacturing (upstream or downstream).
• Experience with quality systems and CAPA/deviation handling.
• Strong communication in English; German proficiency is preferred.

Aufgaben

• Set up and troubleshoot upstream operations in fed-batch GMP manufacturing.
• Ensure GMP and EHS compliance across responsibilities.
• Document process execution, deviations, changes and CAPAs with QA collaboration.
• Contribute to continuous improvement and tech transfer activities.
• Create and update SOPs and electronic batch records; review documentation.
• Manage materials using ERP systems (SAP).
• Mentor junior team members and participate in knowledge transfer.
• Participate in sampling and on-call duties, including weekends.

Kenntnisse

GMP compliance

Upstream processing

Biologics manufacturing

Process troubleshooting

Continuous manufacturing

Problem solving

Team mentoring

English (C1)

German (B2)

Ausbildung

Bachelor’s or Master’s in a relevant discipline

Tools

SAP QM

Veeva Vault

DeltaV

PAS-X

Jobbeschreibung

MSD is seeking a Specialist Upstream Operations in Switzerland to support GMP manufacturing of early-phase biologics. The role requires full-time site presence at Schachen, Zurich area, and involves setting up upstream operations, ensuring GMP compliance, and documentation throughout process transfers and CAPA investigations.

You will mentor junior staff, engage in continuous improvement, and collaborate with QA and other stakeholders.