The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. As the technical lead for sterile drug product transfers, you coordinate cross-functional teams and customer interactions to bring new products seamlessly onto the manufacturing line, driving process setup, scale-up, documentation, and implementation activities. You proactively manage timelines, risks, deviations, CAPAs, and change management processes while maintaining the highest GMP, quality, regulatory, and safety standards. This is an office‑first role. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (one day per week).
Tasks
- Lead the technical transfer and introduction of new sterile drug products from early clinical development through to commercial manufacturing, ensuring a smooth and compliant transition into GMP operations.
- Act as the central point of contact for customers and cross-functional stakeholders, coordinating activities, timelines, risks, and milestones throughout the project lifecycle.
- Drive process setup, scale-up, and implementation activities for aseptic manufacturing, ensuring successful product launch and operational readiness.
- Create and maintain technical documentation, including master batch records, transfer packages, and process implementation documents, while ensuring data integrity and GMP compliance.
- Oversee deviation management, CAPAs, and change controls, supporting inspections, audits, and regulatory activities while maintaining the highest quality, safety, and compliance standards.
Requirements
- Proven experience in aseptic GMP manufacturing, with 3-4 years of relevant experience in the pharmaceutical industry and a strong understanding of sterile operations.
- Solid knowledge of Fill & Finish processes, including hands-on experience supporting manufacturing activities in a regulated environment.
- Strong understanding of GMP requirements and quality standards, with the ability to apply them effectively in day-to-day operations.
- Fluent German and English communication skills, enabling effective collaboration with site teams, global stakeholders, and customers.
- Proactive, detail-oriented, and collaborative mindset, with the ability to coordinate multiple priorities and contribute to the successful introduction of new products into manufacturing.
Benefits
- An agile career and a dynamic work culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits.
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