Summary
Overview
Work History
Education
Skills
Timeline
Generic

Sanaa Amguoune

Manufacturing Operations And Operational Readiness Lead
Copenhagen

Summary

Aseptic manufacturing expert and Talented Manager with team leadership, planning, and organizational skills built during successful career in both operations and projects in an international context with distributed teams.

Smoothly equip employees to independently handle daily functions and meet customer needs. Diligent trainer and mentor with exceptional management abilities and results-driven approach.

Overview

12
12
years of professional experience
5
5
Languages

Work History

Operational Readiness Manager

Novonordisk SA
09.2024 - Current

Overview:

Driving operational readiness for $40B DKK capital expansion program across three continents, focusing on creating cutting-edge manufacturing sites using modular technology to enhance capacity for existing products and launch new offerings.

Key Responsibilities:

  • Directed and mentored project managers and specialists in executing operational readiness plans, including training, SOPs, failure mode risk assessments, supplier support, and hypercare.
  • Cultivated collaboration between training, ITOT, and quality assurance to ensure optimized manufacturing processes (maintain standard, business continuity plans, CAPA readiness, recovery plans).
  • Aligned process design with capacity targets while supporting organizational growth through strategic manning and hiring plans.
  • Defined product transfer strategies, forecasted capacity bottlenecks, and provided technical expertise and implemented solutions for critical business challenges.
  • Communicated effectively with senior leadership to provide progress updates and drive performance metrics.




Operational Readiness Work Package Owner

Novonordisk SA
08.2022 - 09.2024

Overview:

Led operational readiness for a $40B DKK capital expansion program across three continents, focusing on creating cutting-edge manufacturing sites using modular technology to enhance capacity for existing products and launch new offerings.

Key Responsibilities:

  • Scope Definition: Define operational readiness scope and deliverables, ensuring alignment with organizational goals and timelines.
  • Team Development: Recruit and onboard project managers and specialists, equipping them for effective operational readiness execution.
  • Layout Optimization: Collaborate with stakeholders to design initial layouts and optimize physical workflows for manufacturing processes.
  • Simulation Tool Creation: Develop and implement a module simulation tool to enhance and streamline operational workflows.
  • Global Team Coordination: Establish a global team across sites to ensure cohesive execution and best practice sharing.
  • Leadership Collaboration: Work with senior leadership to set strategic direction for the ramp-up phase, ensuring successful implementation and transition

Freelance Consultant

Self-employed
04.2022 - 08.2022

Overview:

GMP, compliance and and engineering expertise, supporting the review of case studies for conceptual design of aseptic manufacturing facilities

Product Owner

Novonordisk AS
11.2021 - 07.2022

Overview:

Led the review and redefinition of product portfolio for new digital team supporting tablet manufacturing.

Key responsibilities:

  • Developed and prioritized product portfolio and backlogs based on stakeholder feedback and market analysis to ensure alignment with strategic goals.
  • Collaborated with cross-functional teams to define product vision and requirements for new features.
  • Conducted user research and gathered insights to refine product offerings and enhance user experience across multiple platforms.
  • Facilitated agile ceremonies such as sprint planning, daily stand-ups, and retrospectives to maintain team alignment and project momentum.

Validation Project Manager

Novonordisk AS
02.2016 - 11.2021

Overview:Promoted from Project Engineer to Project Manager for a DKK 2B greenfield capital expansion project of an aseptic filling facility, leading efforts from CQV through ramp-up.

Key Responsibilities:

  • Validation Execution: Oversee the validation of formulation equipment in scope in alignment with established validation plans, including creating documentation, supplier audits, testing, reporting, and deviation management.
  • MES and ERP Implementation: Serve as the subject matter expert and master data steward for the design and implementation of MES and ERP systems within the formulation area.
  • SOP and Training Development: Create standard operating procedures (SOPs) and training materials, and manage CAPAs and audit presentations during the submission and ramp-up phases.
  • Project Management of MES: Lead the implementation and updates of the MES system across all aseptic processes utilizing agile frameworks

Manufacturing Team Leader

Novonordisk AS
06.2014 - 02.2016

Overview:

Shift leader of technicians team in the formulation of injectable products.


Key responsibilities:

  • Led Manufacturing Operations: Directed daily manufacturing activities to ensure compliance with quality standards and production schedules.
  • People leadership: Hired, managed and trained new employees on safety protocols, equipment operation, and production processes, enhancing team efficiency.
  • Process Optimization: Monitored workflows and implemented process improvements to minimize downtime and facilitate smoother production transitions.
  • Cross-Functional Collaboration: Worked closely with cross-functional teams to identify improvement areas, resulting in optimized operations and cost savings.
  • Incident Analysis Participation: Actively participated in root cause analyses following incidents or near misses, implementing corrective actions to prevent recurrence.

Validation Engineer

Sanofi Aventis
06.2013 - 04.2014

Overview:

Validation Consultant – Fermentation of Hydrocortisone Production

Key Responsibilities:

  • Validation Coordination: Oversee and coordinate validation testing activities for operators.
  • Results Review: Review and approve validation results to ensure compliance with established standards.
  • Problem-Solving Participation: Engage in problem-solving workshops to address operational challenges.
  • Non-Conformity Management: Manage and resolve non-conformities to maintain quality assurance.

Education

Master of Science - Chemical Engineering And Biotechnology

Ecole Centrale De Paris
Paris
04.2001 -

Skills

Team leadership

Operations management

Strategic planning

Decision-making

Communication

Performance management

Project management

MES- ERP- virtual twins

Lean - Problem solving

Timeline

Operational Readiness Manager

Novonordisk SA
09.2024 - Current

Operational Readiness Work Package Owner

Novonordisk SA
08.2022 - 09.2024

Freelance Consultant

Self-employed
04.2022 - 08.2022

Product Owner

Novonordisk AS
11.2021 - 07.2022

Validation Project Manager

Novonordisk AS
02.2016 - 11.2021

Manufacturing Team Leader

Novonordisk AS
06.2014 - 02.2016

Validation Engineer

Sanofi Aventis
06.2013 - 04.2014

Master of Science - Chemical Engineering And Biotechnology

Ecole Centrale De Paris
04.2001 -
Sanaa AmguouneManufacturing Operations And Operational Readiness Lead