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Coline Certain



Both Pharmacist and Engineer, I'm looking for Indusrial Project Management position in a dynamic Pharmaceutical / Life Science company in Rhône-Alpes area from spring 2019.

Experienced project manager, I lead various projects across various dept. of pharmaceutical industry which allowed me to gain good overall vision of organizational and technical process of a pharma company. I acquired expertise in Problem Solving, Industrial Performance, Equipment Reliability, and Contract Manufacturing organizations (CMO) management.
I also have strong skills in decision making, curiosity in several scientific and human areas, effective communication with different levels in and oustide the company which will allow me to be effective fast in a challenging new position.

My international experience in Canada and Japan allowed me to develop various approaches on problems solving and way of working that would certainly be a plus in any organization.

Expériences professionnelles

Project & portfolio manager - external manufacturing

Sanofi K.K. , Tokyo

De Avril 2018 à Aujourd'hui

My mission in the Japanese External Manufacturing team consists in deployment of global strategy regarding portfolio management, CMOs performance monitoring and HSE (Health Safety & Environment) activities.

PPM: Product Portfolio Management
- Deployment and monitoring of global strategy regarding rationalization plan
- Follow-up on transfer / repatriation projects
- Maintaining and updating the Master file for Japan portfolio

HSE activities (Health, safety & environment)
- Strategy and 5 years roadmap definition for HSE audits - PSCI audits (Pharmaceutical Supply Chain Initiative)
- Coordination of HSE activities with global, Japanese CMOs and external audit companies

- Deployment and follow-up of CMO’s performance
- Participation to strategic plan and KPIs (Key Performance Indicators) setting
- KAM (Key Account Management): follow-up on toll and full manufacturing contracts, and support of various procurement and other dept. initiatives
- Follow-up on quality and supply topics with internal teams;

Performance improvement coordinator

Sanofi K.K. , Tokyo

De Mai 2017 à Avril 2018

Sanofi global and regional strategy cascading to site and dept. level
- Deploy and sustain «Sanofi Manufacturing System» standards - Followup site performance plan projects to reach the target savings
- Cascade site priorities and followup monthly on dept. priority projects
- Visual management of Sanofi Standards Performance management:
- Monitor and Analyse Site Scorecards and KPIs; followup with related managers
- Take part in performance workshops: SMED, Gemba Problem Solving (technical recurrent problem on specific equipment: ex closing issues of box flaps)
- Monitor Kaizen conducted in the site: 500/year
- Take part in Kaizen activities: ex line balance for manual packaging
- Organize and participate: monthly performance meeting and Kaizen committee See less

Project engineer

Pharmascience , Mont-royal

De Août 2015 à Juin 2016

- Defined need with dept. leaders and referent persons
- Realized projects feasibility studies
- Planned, coordinated and monitored projects to minimize the impacts on production schedule
- Monitored timetables, budgets and projects quality
- Communicated with external suppliers and contractors : technical discussions, negotiation
- Managed related documentation (CAPEX, URS, commissionnings, etc)
- Coordinated packaging tooling purchases and tests, for new products launching projects
- Advised the product managers on the technical feasibility of packaging for the launching projects
- Participated to the hiring process of an industrial designer and an intern to manage space planning projects
- Trained and supervised intern and new hired for space planning projects

Process validation specialist - projet packaging

Pharmascience , Mont-royal

De Avril 2014 à Août 2015

I joined the Process Validation team as a Project leader in order to implement the validation of packaging in bottles on several lines. The first line impacted were a brand new highly efficient packaging line and the project were then extend to 3 other packaging lines well implanted in another site of Montreal area.

- Defined the validation strategy and critical process parameters (CPP) in accordance with Santé Canada and FDA guidelines
- Drafted and Redacted the validation Protocols and Reports
- Piloted the change management induced by the project by weekly meetings with the several impacted departments
- Planned line stops and the division of work during each project (6 to 8 persons teams)
- Supported the qualification team during the line stops
- Analyzed the validation results and solved the related problems (technicals & humans)
- Implemented the results with the concerned dept.
- Trained operators, mechanics and validation team to understand and respect the validation results
- Generated the related Validation documentation (protocols & reports) and QA documents related to the project (deviations, Change Controls, etc)
- Updated and kept up to date the validation databases and matrix for the packaging in blisters and bottles
- Managed and followed up routine validation batches with planners, technicians, production and QA managers

Equipment reliability analyst

Pharmascience , Mont-royal

De Septembre 2013 à Avril 2014

The goal of my work in the maintenance team was to improve equipments reliability of the most critical equipments, to reduce breakdowns, maintenance correctives interventions and low performance activities of those equipments. This work has been done using the maintenance data of the last 18 months on SAP PM, when it was implemented.

- Led Autonomous and trans-functional projects
- Established the top 3 critical equipments list after data analysis based on breakdowns info extracted from SAP
- Analyzed retrospectively the recurrent problems and breakdowns for targeted equipments : fluid beds, presses,encapsulators
- Organized and piloted multidisciplinary work groups of 3 to 6 persons for problems solving (technical, organisational or human problems)
- Guided the different actors to targeted some projects (mechanics, production specialists and operators, health and safety managers, continuous improuvment team, etc)
- Monitored the corresponding projects with each actor
- Managed the relative QA documentation
- Participated to the continuous improvement projects related to those equipments
- Energy saving projet: Increased performance of 3 HVAC systems of the production building and saved 41k$/year

Formations complémentaires

Docteur en Pharmacie

Universtite Claude Bernard Lyon 1 - Pharmacien - Ingenieur

2006 à 2013

Ingénieur en génie chimique

Ecole Polytechnique Montréal - Biopharmacie

2011 à 2013

Parcours officiels

VIE – JAPON – 2019


Anglais - Courant

Français - Langue maternelle

Japonais - Notions

Allemand - Notions


attention to detail
International projects
third-party management
gestion de la sous-traitance
CMO management
management HSE
Portfolio Management
Key Account Management
Project Management
Project Coordination
Project leading
Supplier management
contractor management
Process engineering
budget monitoring
cross functional projects
priority management
Process validation
packaging process
Change Management
Conduite du changement
Team working
Project team management
Work under pressure
Résolution de problèmes
equipment reliability
Lean Manufacturing
pharmaceutical process