Michael Orlando
Paris
Summary
Inspiring leader, patient centric with 27 years of international experience in PHARMA industry (US, France, Italy), holding various leadership positions in R&D, Manufacturing & Corporate Functions.
Significant exposure in sites & global functions transformation in the context of performance journey and cultural shift.
Expert knowledge in cGMP covering both Biologics & Small Molecules, strong experience with validation & launching of new Biotech facility, introduction of new Product & next generation Process till submission & approval.
Systematically acting as a role model to develop teams and build robust organizations to sustain results & achieve long term strategies while creating an environment of strong teamwork, sense of urgency, engagement & continuous improvement mindset, innovation.
Overview
27
27
years of professional experience
Work History
Global Head of Industrial Performance
Sanofi
Greater Paris Area (Gentilly)
09.2022 - Current
- Leading the 'Connected Smart Factory' strategic program at Global Manufacturing & Supply (M&S) through the definition & execution of Digital and Automation transformation roadmap across the network. Responsible of dedicated Archetype Leaders (DS Biologics & Vaccines, DS Small Molecules, DP Injectables, DP Solids, Quality Control & Analytics, Packaging)
- Responsible of the Sanofi Manufacturing System second generation (SMS 2.0) based on Lean & Factory 4.0 solutions with the strategic ambition to position Continuous Improvement as the key driver to execute the sites' strategic priorities (Compelling Business Needs). Leading the design/codification/deployment of specific ecosystems equipped with best in class operating standards (simplify, standardize, digitize)
- Leading the Global Performance Programs supporting the strategic ambition in performance of M&S (Asset Intensification with McLaren partnership, Flow/Cycle Time, Yield & Batch Performance, Supplier & Sourcing Excellence)
- Responsible of a dedicated team of Global Transformation Leaders in charge of performing on sites & in global functions fast pace and high intensity transformation projects called 'Boosters'
- Framing the annual industrial performance planning in collaboration with Strategy & Finance leveraging external benchmark referential (e.g. Pobos, Saint Gallen, ...). Provide direct support to Global Business Units to monitor and improve performance trajectories (General Medicines, Specialty Care, Vaccines)
Site Lead, General Manager, Biopharmaceutical Site
Sanofi - Specialty Care (Industrial Affairs)
Greater Paris Area (Vitry)
01.2019 - 08.2022
- Inspiring Leader of a multi-products FDA-EMA approved facility delivering monoclonal antibodies and highly potent API to the patients
- Leading a strategic ramp-up program on site to increase by 2.5 fold the biotech capacity with design & execution of dedicated workstreams on Engineering projects, Process optimization & People hiring - on boarding - org design upgrade with night shifts extension
- As part of the Top Decile journey, driving a cultural transformation on performance based on Lean/Operation Excellence methodology & cultural shifts
- Overseeing specific New Product Introduction (NPI) to match with portfolio growth ; this includes the Baculovirus vaccine platform strategic internalization enabling the production of commercial recombinant proteins against covid-19 (VidPrevtyn)
Senior Director Manufacturing
Sanofi Genzyme US
Greater Boston Area (Allston Landing Facility)
09.2016 - 12.2018
- Leading manufacturing operations at the Allston Landing Facility to deliver Cerezyme for the Gaucher disease patients
- Directly contributing to the Certification & Verification phases defined in the Consent Decree with FDA. Operating through continuous third party collaboration on site (Quantic)
- Executing a transformation program to drive significant performance improvement in the context of the certification/verification process with FDA in relation to the Consent Decree
- Outstanding improvement in safety (proactive culture with zero accident per choice), quality (on time closure of DEV/CAPA/CCR/PR), delivery (100% of schedule adherence, improvement in drug substance release cycle time), cost (decrease of destruction, sustainable yield improvement) and involvement (people development, retention of high potentials, attraction of talents in the very competitive greater Boston areas)
- In charge of executing a significant layoff program as part of the strategic orientation change
Head of Biolaunch Facility
Sanofi Biologics (Industrial Affairs)
Greater Paris Area
02.2014 - 08.2016
- Responsible of a cGMP biotech plant producing commercial and clinical batches of monoclonal antibodies
- Driving an overall transformation of the facility with Mc Kinsey support to upgrade the org design, process & systems in order to successfully validate new biotech product
- Improving daily operations performance through lean methodology & cultural journey with all our cross-functional teams
Head of Bio Manufacturing Operations
Sanofi R&D, Global Biotherapeutics
Greater Paris Area
06.2010 - 01.2014
- Responsible of manufacturing of recombinant protein/mAb batches in a cGMP multi-product Pilot Plant offering scales from 200L to 1000L bioreactors
- Providing agility and patient centricity to manage product change over while maintaining flexibility between single use technologies and stainless steel vessels
- Managing the MCB/WCB manufacturing operations for the overall R&D portfolio
- Driving process improvement & innovation at Pilot scale in support to R&D portfolio and commercial operations
Global CMC Project Coordinator & Attaché of Sr VP
Sanofi Global CMC (R&D)
Greater Paris Area
04.2006 - 05.2010
- In charge of leading the CMC Program Management for the global R&D portfolio incl. drug substance & drug product, small molecules & biologics, LCM
- Member of the Global CMC Leadership Team
- Attaché of the Sr VP, Global Head of CMC (R&D)
- Secretary of the Global CMC Project Council & the Joint Manufacturing Committee with Regeneron Pharmaceuticals
CMC Coordinator for Clinical & Commercial Products
Sanofi, Science & Medical Affairs
Greater Paris Area
01.2005 - 03.2006
- Management of CMC activities incl. process & analytical development, GMP clinical supplies, Industrialization, LCM for R&D candidates and commercial product (Enoxaparin, active ingredient of Lovenox)
- Successfull completion of the Semuloparin process to Singapore facility
Process Development Project Manager, Lovenox Team
Aventis Pharma, Industrial Operations
Greater Paris Area
09.2003 - 12.2004
- Responsible of LCM program with regards to the active ingredient of Lovenox (Enoxaparin API)
- In charge of lab scale development & industrial support to improve productivity & sustain performance
Head of Biotech Development Department
Aventis Bulk, Industrial Operations (ITALY)
Brindisi
09.2001 - 08.2003
- Responsible of the implementation of the MSAT biotech process development laboratories incl. WCB manufacturing, screening & mutagenesis of new strains, fermentation optimization at small/pilot scales
- Responsible of the seed trains for commercial operations
- Successfully passed FDA inspection for the Cell Bank activities
Research Scientist, Process Development Biotech
Rhône-Poulenc Rorer then Aventis Pharma
Greater Paris Area
09.1997 - 08.2001
- In charge of fermentation process development in support to an industrial site
- Responsible of the new process industrialization from 20L to 220,000L bioreactors
Process Development Engineer
Grands Moulins de Paris (Food Industry)
Greater Paris Area
09.1996 - 08.1997
- Responsible of process development activities & industrial support for commercial products
Education
M.D. - Biochemical Engineering
06.1996
Skills
- Swift & agile
- Strategic thinking
- Digital transformation
- Provides inspiration with "can do" attitude
- Regular exposition to Regulatory Agencies (FDA, EMA, Health Canada, ANSM, )
- Culture of excellence and performance through lean basics
- Able to turn vision into a reality
- Stimulated by challenges & problem solving
- Alert to changing situations and act quickly to get results
- Constantly strives towards self improvement
- Comfortable with complex decision making
- High sense of urgency
- Providing enthusiasm & positive energy to engage teams
- Operating in complex environment, network oriented by creating partnership and best practices sharing
- Deep knowledge of biotech & pharma manufacturing technology
- Statistical Data Analysis
Additional Information
- Member of the Innovation Council at the Conference Board
- Member of the Saint Gallen Research Group in Operational Excellence
Timeline
Global Head of Industrial Performance - Sanofi
09.2022 - Current
Site Lead, General Manager, Biopharmaceutical Site - Sanofi - Specialty Care (Industrial Affairs)
01.2019 - 08.2022
Senior Director Manufacturing - Sanofi Genzyme US
09.2016 - 12.2018
Head of Biolaunch Facility - Sanofi Biologics (Industrial Affairs)
02.2014 - 08.2016
Head of Bio Manufacturing Operations - Sanofi R&D, Global Biotherapeutics
06.2010 - 01.2014
Global CMC Project Coordinator & Attaché of Sr VP - Sanofi Global CMC (R&D)
04.2006 - 05.2010
CMC Coordinator for Clinical & Commercial Products - Sanofi, Science & Medical Affairs
01.2005 - 03.2006
Process Development Project Manager, Lovenox Team - Aventis Pharma, Industrial Operations
09.2003 - 12.2004
Head of Biotech Development Department - Aventis Bulk, Industrial Operations (ITALY)
09.2001 - 08.2003
Research Scientist, Process Development Biotech - Rhône-Poulenc Rorer then Aventis Pharma
09.1997 - 08.2001
Process Development Engineer - Grands Moulins de Paris (Food Industry)
09.1996 - 08.1997
National Institute For Applied Sciences (INSA) - M.D., Biochemical Engineering
Similar Profiles
Albin AugustyAlbin Augusty
Chemical Technician II at SanofiChemical Technician II at Sanofi
Collin DumasCollin Dumas
Area Business Manager, Hematologic Oncology at SanofiArea Business Manager, Hematologic Oncology at Sanofi
Justin HaylockJustin Haylock
Digital Product Owner at SanofiDigital Product Owner at Sanofi