Michael HAZIME
Lyon
Summary
Dynamic and results-driven project leader with extensive expertise in equipment validation, process reliability, and GMP compliance. Proven ability to lead cross-functional international teams, drive continuous improvement initiatives, and optimize manufacturing processes. Adept at leveraging Performance metrics and operation tools to managing large-scale projects while fostering a culture of safety and quality. A dedicated mentor and team builder with a strong focus on achieving operational excellence and aligning goals with organizational objectives.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Tech Transfer and New Vaccines Project Manager
Sanofi
Lyon
01.2023 - Current
- Team Leadership: Directed cross-functional and international teams to deliver high-impact industrial transfer projects with a cumulative budget of €45M. Ensured alignment with organizational goals, fostering collaboration, and accountability across departments.
- Process Reliability and Optimization: Achieved a 15% improvement in operational efficiency by implementing and continuously monitoring KPIs such as OEE, and RFT, leveraging statistical analysis tools such as statistical process control.
- Equipment Validation and Qualification: Oversaw the qualification and validation of new equipment and processes to ensuring compliance with GxP guidlines. Successfully reduced validation cycle times by 10% through streamlined protocols and timeline optimization for parallelization of processes.
- Risk Analysis and Mitigation: Performed continuous and comprehensive risk analyses for new equipment integration and process changes. Put in place developing mitigation plans to reduce unforseen problems and bottlenecks.
- GMP Compliance and Documentation Management: Ensured strict adherence to Good Manufacturing Practices (GMP) by implementing and maintaining robust documentation systems (protocols, SOPs, etc). Standardized documentation processes regulatory compliance, reducing errors by 20%. Successfully prepared and led teams through internal and external audits decreasing non-conformance.
- Root Cause Analysis: Investigated equipment failures and process deviations using root cause analysis methodologies, incorporating advanced data tools like SAP and Excel-based statistical models to identify issues and implement corrective actions.
- Change Management: Led cross-functional change initiatives to incorporate new equipment and processes into manufacturing workflows. Facilitated seamless transitions through targeted training, process updates, and stakeholder alignment.
- International Collaboration: Worked closely with global design teams and external vendors to ensure equipment and processes were tailored to production needs, conducting on-site validation and process reviews in multiple countries.
Life Sciences Project Manager
Capgemini
Lyon
04.2022 - 12.2022
- Clinical Study Setup and Execution: Coordinated the creation and maintenance of clinical protocols, focusing on IMP/NIMP forecasting, packaging specifications, and distribution strategies to ensure alignment with global study requirements.
- Team Supervision and Goal Setting: Supervised a team of clinical supply chain specialists, setting clear performance goals and deadlines to meet project timelines and quality benchmarks. Provided regular feedback to team members, ensuring alignment with organizational priorities and fostering professional growth.
- Delegation and Task Management: Delegated tasks effectively across team members, ensuring optimal use of resources and maintaining high levels of accountability within the team.
- Stakeholder Collaboration: Acted as the primary contact for Global Study Managers (GSMs), ensuring seamless communication between clinical operations, packaging teams, and external suppliers.
- Documentation and Compliance: Reviewed and managed critical documents such as protocols, labeling specifications, and pharmacy manuals to ensure compliance with GMP and GDP standards.
- Risk and Resource Management: Monitored the consistency of study needs with clinical data, updating forecasts and schedules to proactively address resource and timeline constraints.
- Supply Chain Optimization: Supervised labeling and packaging processes, ensuring timely delivery and alignment with the regulatory and operational requirements of clinical trials.
- Study Closure Activities: Oversaw reconciliation and destruction activities for clinical supplies, ensuring compliance with regulatory guidelines and audit readiness.
Agile Project Manager
Sanofi
Paris
10.2020 - 11.2021
- Team Leadership and Development: Supervised international, multidisciplinary teams to implement Agile methodologies, fostering collaboration and alignment across departments.
- Set performance goals: put in place KPIs for team efficiency and monitored progress that lead to a 20% increase in efficiency post agile implementation. Provided regular feedback to ensure team success and professional growth.
- Scrum Ceremonies and Backlog Management: Facilitated Scrum ceremonies, ensuring alignment with project objectives. Collaborated with product managers to prioritize backlogs based on strategic goals and team capacity, improving delivery timelines by 10%.
- Agile Process Implementation: Led the transition to Agile frameworks such as Scrum and SAFe, introducing tools like Jira and Confluence to optimize workflows and enhance transparency across teams.
- Training and Change Management: Conducted training sessions on Agile principles and tools, enabling teams to adopt Agile practices effectively. Supported change management initiatives, including process updates and resource planning, ensuring smooth transitions within the organization.
- Cross-Functional Collaboration: Acted as the primary liaison between senior leadership and operational teams, translating high-level objectives into actionable plans. Facilitated governance meetings to maintain alignment across departments and track progress.
PhD Candidate
INSERM U1239
Rouen
02.2016 - 12.2019
- Team Leadership and Mentorship: Supervised and mentored a team of junior researchers and technicians, providing guidance on project execution, task prioritization, and skill development, fostering a collaborative and high-performing team environment.
- Project Coordination and Planning: Managed multiple research projects simultaneously, ensuring alignment with timelines, objectives, and resource availability while coordinating with cross-disciplinary teams.
- Cross-Cultural Collaboration: Partnered with international research teams to align goals, methodologies, and outcomes, enhancing the efficiency and impact of collaborative projects.
- Change Management: Adapted workflows and team structures to meet evolving research objectives, ensuring seamless transitions and maintaining project momentum.
- Documentation and Communication: Produced comprehensive reports and presentations for internal stakeholders and international collaborators, effectively communicating project progress and findings.
- Problem-Solving in Team Dynamics: Addressed team challenges, such as task overlap or resource constraints, by implementing clear role definitions and proactive conflict resolution strategies.
Education
Master of Science - Strategic Project Management
CESI
Rouen09-2021
Ph.D. - Neuroscience
Universite De Rouen
Rouen12-2019
Skills
- Project development
- Budget management and resource allocation
- Feasibility analysis
- Team Supervision and Mentorship
- Task Delegation
- Coaching and Feedback to Teams
- Cross-Functional and International Team Collaboration
- Agile Methodologies (Scrum, SAFe)
- Risk Analysis and Mitigation Planning
- Process Optimization and Performance Improvement
- Equipment Qualification and Validation
- Root Cause Analysis (RCA) and Statistical Analysis
- GxP and EHS Compliance
- Process and Equipment Scale-Up
- Resource Allocation and Project Planning
- KPI implementation & Monitoring
- Regulatory Audit Preparation and Support
- Process standardization
- Data analysis
- Jira and Confluence
- MS project
- Office 365
Certification
- Google Project Management
- Agile with Atlassian Jira
- Professional Scrum Master
- Certified SAFe 5 Scrum Master
Languages
English
First Language
French
Advanced (C1)
C1
Arabic
Proficient (C2)
C2
Timeline
Tech Transfer and New Vaccines Project Manager
Sanofi
01.2023 - Current
Life Sciences Project Manager
Capgemini
04.2022 - 12.2022
Agile Project Manager
Sanofi
10.2020 - 11.2021
PhD Candidate
INSERM U1239
02.2016 - 12.2019
Master of Science - Strategic Project Management
CESI
Ph.D. - Neuroscience
Universite De Rouen
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