Stability & Raw Materials QC Lead — GMP Lab

Incyte Corporation; Yverdon-les-Bains; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Incyte Corporation is seeking a QC Specialist for Stability and Raw Materials at its Bioplant in a highly regulated environment. You will plan stability testing, coordinate RM lab activities, and ensure timely data review and release in collaboration with QA, Manufacturing, and external labs.

The role demands strong GMP knowledge, pharmacopoeial familiarity, and fluency in French and advanced English, with leadership in deviations and CAPA within QC operations.

Qualifikationen

• Bachelor with 5 years of lab experience, or CFC/BTS with at least 10 years in a laboratory.
• GMP experience in a pharmaceutical/biotechnology setting.
• Deep knowledge of analytical testing and pharmacopoeias.
• Ability to work in a highly regulated and fast-changing environment.
• Highly developed team spirit and proactive mindset.

Aufgaben

• Plan and coordinate RM lab activities for the team of technicians.
• Coordinate design, initiation, and execution of stability studies per ICH/regulatory requirements.
• Collaborate with QC analysts and lab supervisors to ensure timely testing.
• Serve as primary contact for stability-related queries across QC/QA/Manufacturing/Regulatory.
• Support regulatory submissions with stability data and summaries.
• Participate in cross-functional meetings to report study progress and timelines.
• Own deviations, CAPA and change controls for QC activities.
• Review and maintain SOPs, WIs, and related quality documents.
• Define RM specifications test methods per USP/Eur.Ph./JP/BLA and beyond
• Interface between Analytical Transfer & Validation and QC Microbiology for new product introductions
• Ensure communication between QA, Manufacturing, Supply Chain, Warehouse and External labs

Kenntnisse

GMP experience

Analytical testing

Regulatory compliance

Quality systems

Team collaboration

Ausbildung

Bachelor's degree in Physico-chemistry/Biotechnology

C FC / BTS in Physico-chemistry/Biotechnology

Jobbeschreibung

Incyte Corporation is seeking a QC Specialist for Stability and Raw Materials at its Bioplant in a highly regulated environment. You will plan stability testing, coordinate RM lab activities, and ensure timely data review and release in collaboration with QA, Manufacturing, and external labs.

The role demands strong GMP knowledge, pharmacopoeial familiarity, and fluency in French and advanced English, with leadership in deviations and CAPA within QC operations.