Senior QC Scientist (cGMP) – Reference Standards Lead

Lonza; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Visp, Switzerland, seeks a QC/CSM liaison to author, revise and review GMP reference standard qualification protocols and reports, enabling LIMS/LES activities for biotechnological reference materials.

You will mentor colleagues, support change management, lead innovation projects, and provide SME input during audits while ensuring data integrity and safety in collaboration with QC leads, QA Analytics, and external clients.

Reference: R78845

Qualifikationen

• Master’s degree or equivalent experience in a Life Sciences discipline (Biology, Chemistry or related field).
• Proven experience in a cGMP environment – experience in quality control or analytical development preferred.
• Exceptional technical writing skills.
• Advanced scientific experience in analytical chemistry/biology.
• Extensive knowledge with QC relevant software (e.g. LIMS/LES, DMS, Trackwise, Statistica).
• Team player.
• Change readiness.
• Proficiency in English required – proficiency in German preferred.
• Excellent project and time management skills.

Aufgaben

• Primary point of contact between QC customer and CSM for authoring, revising and reviewing of GMP reference standard qualification protocols and reports, primarily for biotechnological reference materials.
• Timely completion of qualification protocols and reports enabling LIMS/LES-related activities (MLP specifications, test schedules) and support thereof
• Providing technical mentoring and coaching to colleagues within and outside the team in a matrix environment.
• Support quality documentation and change management process for reference standards, including review, revision, and timely completion of Trackwise records.
• Leading innovation projects within the area of responsibility and identifying opportunities for cost and efficiency optimization.
• Providing SME input for project-specific topics during audits and inspections.
• Compliance with quality, data integrity, and safety requirements.
• Collaboration with QC project leads, QA Analytics, as well as external clients.

Kenntnisse

cGMP experience

Technical writing

Analytical chemistry/biology

English

German (preferred)

Project management

Team player

Change readiness

Ausbildung

Master’s degree in Life Sciences

Tools

LIMS/LES

DMS

Trackwise

Statistica

Jobbeschreibung

Lonza in Visp, Switzerland, seeks a QC/CSM liaison to author, revise and review GMP reference standard qualification protocols and reports, enabling LIMS/LES activities for biotechnological reference materials.

You will mentor colleagues, support change management, lead innovation projects, and provide SME input during audits while ensuring data integrity and safety in collaboration with QC leads, QA Analytics, and external clients.

Reference: R78845