Marcelo Luna

CargoDiretor de Manufatura - Pfizer

Summary:

 

Chemical Engineer (M.Sc.); Corporate Finance (MBA);

 

  • Joined Pfizer Pharmaceuticals Inc. in 1995, at the Guarulhos Site – SP, Brazil.

 

  • Current position: Manufacturing Director – Itapevi Site – Pfizer Brazil, reporting directly to a Senior VP, located at Pfizer headquarters in NY – USA.

 

  • 22 years of experience on the manufacturing pharmaceutical environment.

 

Current Role: Accountable for Pfizer’s single manufacturing facility in Brazil at Itapevi city – São Paulo. The Site is designed to full manufacture (solids, liquids and semisolids) or perform secondary packaging and supply a wide sort of pharmaceutical formulations to the local market and also to export for LA. This facility is also responsible for the release of all imported FG.

 

2   Professional Career in Pfizer

 

  • Manufacturing Director in Brazil 2016 – Present

 

Relocated to Itapevi Site on April 2016, to conclude the product transfer strategy (as a result of the Guarulhos Site sale) and stabilize that renewed operation by achieving supply steady-state now with a greater manufacturing portfolio.

 

The site has 400+ employees and produces & delivers a wide sort of pharmaceutical formulations, using its 7 different technologies/capabilities: General Solids, Hormones, Psychotropic, Immunosuppressive, Suppositories, Liquids and Cold Chain secondary packaging.

 

 

  • Manufacturing Director in Brazil 2009 – 2016

 

Relocated to Brazil in 2009 – Guarulhos Site, to turnaround the largest/only Pfizer’s combined Human & Animal Health manufacturing operation in Latin America. The site (located in Guarulhos city – São Paulo, used to have 600+ employees (at 3 shifts – 24×7) and produced & delivered a wide sort of pharmaceutical formulations, such as : Ointments, Capsules, Coated Tablets, Sterile Injectables, sterile Ampoules.

 

That Pfizer Site used to hold most of the top regulatory agency certifications since it exported to 70 markets across the globe including: USA, Canada, Latin America, Western Europe, Australia and Japan.  It used to supply Human Health products locally and across LA and was a global supplier for Zoetis (Animal Health) for its sterile injectables (Dectomax, Draxin, Cerenia, Rimadyl, among others). The Site was conveyed to Zoetis on March 2016 and is no longer part of Pfizer network.

 

  • Manufacturing Director in Venezuela 2005 – 2009

 

Relocated to Venezuela in 2005 – Valencia Site, to perform the consolidation of the two manufacturing Sites (East and West) into a single one, following by the preparation for the divestment of the other.

 

During that four years was in charge of the two local existent Manufacturing Pfizer Sites placed in Valencia – Carabobo state, that combined produced a wide sort of pharmaceutical goods for both local & regional markets for Human (Solids, sterile powders, vaccines, ointments, syrups, lyophilized vials) Consumer and Animal Health Divisions.

 

2   Professional Career in Pfizer (continuation)

 

      Before 2005

 

  • Plant Controller – Finance Manager            2001 – 2005       (Guarulhos Site and former Jandira Site)
  • AH* Premix Plant & Technology Manager 1998 – 2000       (*Former AH Feed Additive Premix Plant, now Phibro Inc.)
  • Production Supervisor API* Plant 1995                 (*Former AH API Basic Plant, now Phibro Inc.)

 

3   Professional Career before Pfizer

 

  • Researcher (Fermentation area – Brazil) 1988 – 1995 (Biotech Research Center – Joinville / SC – Brazil)
  • Researcher (Fermentation area – France) 1993     (Universitè Technologie – UTC    Compiegne- France)

 

4   Academic Qualifications

 

Lieutenant – Engineering                                  1983     (CPOR São Paulo – Army Battle reserve)

Chemical Engineer                                          1988     (Mauá Engineering School)

Master in Science degree – Chemical Engineer     1995     (University of São Paulo – Poli-USP)

Business Administration – Specialization               1996     (Getúlio Vargas Foundation – FGV – SP)

MBA – Corporate Finance                                  1999     (University of São Paulo – FEA/FIA)

Business Administration – Specialization               2002     (Don Cabral Foundation – FDC)

 

5   Abilities and successful experiences on:

 

  • Debottleneck production & increase productivity in manufacturing operations with wide level of complexity.
  • Manage the use of suitable capital investment for: Plant overhauling / productivity gains / capacity increase.
  • Built high performing teams, that can successfully change their mindset to become customer focused/business oriented.
  • Promote organization chart optimizations that can deliver in return a better operational performance & management.
  • Developing people and stablish a solid succession plan and talented colleagues pipeline
  • Promote the achievement of high standards in Safety and Quality. Understands and embraces cultural diversity.

 

6   Major accomplishments in Pfizer as the Head of the Manufacturing operation during the last 12 years

 

(2009 – 2017) Brazil

 

  • Lead locally all related activities and conclude the Guarulhos Site spinoff from Pfizer to Zoetis.
  • Implement a customer focused manufacturing culture, followed to staff administrative reorganization in each of the Sites under his administration.
  • Managed meaningful capital investment in order to overhaul installations and duplicate the capacity particularly for the sterile injectable facility/area (Guarulhos).
  • Implement initiatives in both Sites to reorient colleagues to focus on productivity gains (based on OEE and KPI’s), with substantial results on shop floor performance, allowing the Site to increase output, nevertheless with a thigh control on headcount.
  • Promote an audit readiness culture (“inspection readiness” QO, EHS, etc…) & compliance focus. Flawless results on FDA/VMD re-certifications (for GRU specifically) and good results for Sarbane Oxley – SOX and internal audits (both Sites).
  • Created a high performing and talented team and succession plan/talent pipeline across all areas.

 

(2005 – 2009) Venezuela

 

  • Consolidate the two existent facilities into one high performing Site along with product transfer and capital investments. Exit the idle site and prepare it for divestment/sale.
  • Maximized output and sustain high Customer Service level on a complex market growth with double digit inflation.
  • Helped & supported local business growth, by addressing operational bottlenecks with tailored capital investment (balancing cost & volume absorption) to promote a plant overhauling, resulting in significant capacity increase.
  • Managed unions and external political & economic environment during this period of time.
  • Reorient colleagues to focus on productivity gains and introduce the OEE concept on the Site, which increased production performance, allowing the Site to enhance output.
  • Created a high performing and talented team and succession plan/talent pipeline for key areas.

 

 

 

7   Major accomplishments as Production Manager / Plant Controller (1998 – 2005) and as a Researcher (1988 – 1995)

 

Plant Controller (Pfizer)

  • First preparation/work/implementation for SOX corporate audit in Pfizer Manufacturing Site in Brazil.
  • Support to commercial areas on the Divestment/Spin off of legacy WL & Pharmacia consumer business.
  • Integration & unification of Legacy Warner Lambert and Pharmacia cost accounting departments after acquisitions.
  • Support to legacy Pfizer Feed Additive Basic Plant divestiture & Site sale and Site Services management during transition to new owner.

 

Production manager (Pfizer)

  • Production: Feed Additive Basic Plant divestiture and Site Services management during transition to new owner.
  • Support to successful Feed Additive Basic Plant preparation for first FDA pre-inspection.
  • Production optimization (fermentation) by the use of chelate compounds.
  • Introduction of DEMAIC concepts and implementation of KPI’s for fermentation process improvement

 

Researcher (Previous job)

  • * Patent issued under #PI9101469-7 (Semi-continuous Lactic fermentation process) about the reuse/transformation of the cheese whey by fermentation into an alternative source of Urea (the Ammonium Lactate) for Cattle.
  • Several developments projects (partnering with the industry) for fermentation process optimization and scale-up.

 

8   Languages:

 

  • Portuguese (Native) —                Spanish (Fluent)              —           English (Fluent)               —      French