Stability & Raw Materials QC Lead (GMP)

Incyte; Yverdon-les-Bains; Presencial; CHF 120.000 - 150.000; Jornada completa

Descripción de la vacante

Incyte in Yverdon-les-Bains, Switzerland, is seeking a QC Specialist Stability and Raw Materials to lead stability studies and RM testing within the QC Bioplant. You will plan activities, define analyses, coordinate sample shipments to outsourcing labs, and ensure timely data review and approval.

You will act as main contact across QA, Manufacturing, Supply Chain, and external labs; oversee deviations, CAPA, and change controls, and contribute to health authority inspections.

Formación

• Bachelor with 5 years experience or CFC/BTS in Physico-chemistry or Biotechnology.
• Strong GMP experience in pharmaceutical/biotech environment.
• Fluent French and advanced English (C1).

Responsabilidades

• Plan and coordinate RM lab activities for the team of technicians.
• Coordinate design, initiation, and execution of stability studies per ICH and regulatory requirements.
• Collaborate with QC analysts and lab supervisors to ensure timely testing completion.
• Act as primary contact for stability-related queries across QC, QA, Manufacturing, Regulatory Affairs, and Supply Chain.
• Support regulatory submissions by providing stability data and summaries.
• Participate in cross-functional meetings for updates on stability studies and timelines.
• Own on-time execution of stability programs and stability reporting.
• Execute data review for Stability and RM testing.
• Create and maintain SOPs and related quality documents.
• Define RM specifications per reference documents (USP, Eur. Ph., JP, BLA).
• Interface between Analytical Transfer & Validation and QC Microbiology when introducing new products.
• Ensure effective communication across QA, Manufacturing, Supply Chain, Warehouse, QC, and external labs.
• Contribute to health authority inspections and internal/corporate audits.
• Own deviations, investigations, CAPA, and change controls.
• Promote a culture of quality, integrity, and ethics in business.
• Adhere to legal and company guidelines.

Conocimientos

GMP experience

Analytical testing know-how

Proposal making

Synthesis

Rigorous and organized

Team spirit

Proactivity

Pragmatism

French fluent

English advanced

Educación

Bachelor degree in Physico-chemistry / Biotechnology or CFC/BTS

Descripción del empleo

Incyte in Yverdon-les-Bains, Switzerland, is seeking a QC Specialist Stability and Raw Materials to lead stability studies and RM testing within the QC Bioplant. You will plan activities, define analyses, coordinate sample shipments to outsourcing labs, and ensure timely data review and approval.

You will act as main contact across QA, Manufacturing, Supply Chain, and external labs; oversee deviations, CAPA, and change controls, and contribute to health authority inspections.