QC External Manufacturing Digitalization & Process Improvement Intern

Location Morges, Switzerland

Department Technical Operations – GSMO / Global Biologics External Manufacturing

Position Summary

The QC External Manufacturing Digitalization & Process Improvement Trainee will support the optimization, digitalization, and harmonization of QC External Manufacturing processes.

The trainee will mainly contribute to two workstreams: optimization of commercial stability activities in LabWare LIMS and digital inventory management for critical reagents and reference standards. The scope will include process simplification, automation, data visualization, user documentation, training materials, and coordination across teams.

Key Objectives

• Simplify, standardize, and digitalize QC External Manufacturing processes.
• Reduce manual activities and improve access to operational data.
• Support harmonization, user adoption, and knowledge sharing across teams.
• Deliver sustainable digital tools, templates, and implementation recommendations.

Responsibilities

Workstream 1 | LIMS Stability, AI & Digital Lean

Support lean optimization and harmonization of commercial stability processes in LabWare LIMS.

Activities

• Map the current LIMS stability workflow and identify time-consuming, repetitive, or insufficiently documented steps.
• Design standardized and reusable LIMS protocol drafts/templates for recurring commercial stability studies, reducing the need to recreate similar protocols for each new batch.
• Assess opportunities to harmonize stability setup and ways of working across teams.
• Support improvement of AI-assisted data transcription and the transition of the current approach from ChatGPT to Microsoft Copilot, based on defined business use cases and user review requirements.
• Update existing work instructions to reflect actual routine use and support creation of a dedicated work instruction for AI-assisted data transcription.
• Develop user-friendly training materials, such as PowerPoint modules, quick-reference guides, process maps, and short instructional videos.
• Explore solutions for automated extraction, trending, and visualization of approved LIMS stability data, including Power BI or other suitable analytics tools.
• Identify further opportunities for automation, reporting, reminders, or simplified user interactions within the end-to-end stability process.

Potential Deliverables

• Current-state process map and prioritized improvement backlog.
• Standard LIMS protocol draft/template concept and pilot examples.
• Updated LIMS work-instruction content and AI-assisted transcription WI draft.
• LIMS and AI user-training package, including presentation, quick guide, and video content where appropriate.
• Assessment of opportunities and requirements for stability trending and reporting based on available LIMS data.
• Harmonization recommendations and implementation roadmap.

Workstream 2 | Digital Inventory Management for Critical Reagents & Reference Standards

Support implementation of a standardized and digital inventory oversight approach for materials used by CMOs and external testing laboratories.

Activities

• Map current inventory-management practices and information flows for critical reagents and reference standards across products, CMOs, repositories, and testing laboratories.
• Support definition of the minimum data set required for inventory and lifecycle oversight, including material identity, lot, location, stock, status, expiry or requalification dates, usage, lead time, replenishment needs, and responsible owner.
• Help establish consolidated inventories and controlled tracking tools in alignment with the applicable procedures and process owners.
• Develop or improve digital trackers and Power BI dashboards for stock visibility, review status, expiry monitoring, consumption trends, forecasting, replenishment actions, and data gaps.
• Assess opportunities to reduce manual consolidation and introduce reminders, alerts, standardized data collection, or other appropriate automation.
• Evaluate opportunities to share best practices and identify relevant areas for harmonization across teams, while considering their specific needs and ways of working.
• Develop user guidance and training materials to support sustainable operation of the inventory process.

Potential Deliverables

• Current-state assessment and harmonized data model.
• Consolidated critical reagent and reference standard inventory structure.
• Digital monitoring solution or proof of concept, where feasible.
• Standard review, reconciliation, and escalation workflow.
• User guide and training package.
• Implementation and sustainability roadmap, including ownership and maintenance recommendations.

Additional Responsibilities

• Coordinate with relevant stakeholders and gather user requirements.
• Support pilot implementation, user testing, and change-management activities.
• Prepare project updates, documentation, and recommendations.

Operational Support

The trainee will dedicate part of the internship to supporting routine QC External Manufacturing activities, including coordination and follow-up of stability and analytical activities, data consolidation, documentation, reporting, and participation in relevant team meetings.

Candidate Profile

Education

Currently pursuing or recently completed a degree in one of the following or a related field:

• Life Sciences or Pharmaceutical Sciences
• Data Analytics or Business Analytics
• Digital Transformation or Information Systems
• Industrial Engineering or Process Excellence

Preferred Skills

Technical

• Microsoft Power BI and advanced Excel
• Microsoft 365 and Copilot
• Process mapping and workflow analysis
• Data visualization and dashboard development
• Interest in LIMS, laboratory processes, or pharmaceutical quality systems
• Ability to create clear documentation and digital training content

Soft Skills

• Structured and analytical mindset
• Curiosity, creativity, and willingness to learn
• Clear written and verbal communication
• Autonomous, proactive, and comfortable coordinating stakeholders
• Attention to detail and respect for data integrity
• Ability to work across functions and translate user needs into practical solutions

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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