Grupo Loeffler Russek

Responsible of Laboratorios Russek P&L and Entire Pharma Operations at the group on Mfg, Eng/Projects, 

Quality, R&D, Regulatory Afairs and Operations excellence on the Sterile, Oral Liquids & Solids facilities, 

Supply & Procurement Processes strategy development and budget delivery & implementation, New Product 

launches and capital projects implementation, efficiency improvements & CMO/CDMO projects & Supply.

Delivered Results:

Net Sales 1000 Mn MxP, Net profit from +6% to +11%, COGS reduction 19% (67% to 56.4%),

GMP´s renewal project, to provide supply continuity on Products revenues +1000 Mn MxP 

Formula Optimization & Marketing Authorizations renewals, Several Projects and Tech Transfer to support 

supply and compliance (API,Mfg site Chg, Cost Improving). CMO supply & new projects to improve the Cost 

Absortion, New Product Launches of 1+ Million MxP & R&D process implementation & one patent s.

S&OP process implementation & Inventory Control, improvement on coverage for Impulse channel.

Cost variations reduction on COGS impact (+$500 TUSD per year)

Overall Equipment Efficiencies, improving Mfg & Pkg productivity operations. +15% volume & -33% cost (2Yr)

COGS & Conversion Cost Savings Projects of 500-1000 KUSD/ Year, Capital expenditure projects +0,5-3 Mill 

USD

Regulatory Marketing Authorizations maintenance and new submissions & remediations

Technical Director.

Responsible of Mex Site on Mfg & Packaging, Quality, R&D, EHS, Eng, Regulatory Afairs and Operations 

excellence on the Sterile Ophthalmic and Solids facilities, strategy development and budget delivery & 

implementation, New Product launches and capital projects implementation, efficiency improvements & 

CMO/CDMO projects.

Delivered Results:
GMP´s renewal project >7,6 Mn USD, to provide supply continuity on Products revenues 800 Mn MxP 
Formula Optimization & Marketing Authorizations renewals (1st sales product renewal after 10 yr recovered)
Several Projects and Tech Transfer to support supply and compliance (API Mfg site Chg, Cost Improving).
GMP certificacion renewal on Peru & México – DIGEMID & COFEPRIS (PICS)
New Product Launches of 1 Million USD & R&D process implementation & one patent submission
S&OP process implementation, New products launches & Countries integration & Inventory Control.
SAP Cost variations reduction on COGS impact (+$500 TUSD per year)
Overall Equipment Efficiencies, improving Mfg & Pkg operations
COGS & Conversion Cost Savings Projects of 500-1000 KUSD/ Year
3 consecutive years delivering below budget (5-10%).

Mex Plants Director.

Responsible of Mfg & Packaging Proceses On the three facilities (Agropecuarian products, Antibiotics, High Potent and General drugs, budget, launches and capital projects implementation, efficiency improvements.

Delivered Results:
• Get the GMP certificate with no GMP observations for Colombian products (INVIMA), GMP's  recertificación for México,
• To Provide continuity on all Pharma and high potent products 22 billions of MxP
• Improve the service level from below 60% up to 90% in 4 months
• High potent & Pharma facility refurbishing to update the GMP's at the plant
• Implement KPI and lean techniques on Agro, Antibiotics facilities and I move the current status at High potent & Pharma.
• Improve the labor cost on processes at Pharma 
• Spare parts management improvement.
• Develop and deploy the Oral Solid Dosage Forms Strategy for the Company.
  

Operations Director Sterile Processes.

Responsible of Mfg & Packaging Sterile forms, budget, launches and capital projects implementation, efficiency improvements.

Delivered Results:
• Support to get the GMP certificate with no GMP observations - Provide continuity on Sterile Operations
• Develop customers & Sign medium-long term contracts for Mfg (>5 customers
• Energy savings Projects (natural gas, electrical source reducción Projects) 25% saving
• Perform reorganizational Structure to improve productivity linked to MBO and Technical Training.
• Reliable training matrix to support GMP & operation
  

Pharmaceutical Operations Consultant

Supporting the Pharmaceutical companies on Operations/ Supply and Quality strategies, execution plans and follow up to ensure reliable Production and Supply of Pharmaceutical products. New portfolios proposals and API sourcing

Delivered Results:
• Support to get the GMP certificate. & Supply continuity on API sourcing
  

Solids Plant Director-Full time Consultant

Responsible of Mfg & Packaging Solids, Semisolids and liquids forms, budget, launches and capital projects implementation, efficiency improvements.

Delivered Results:
• Support to get the GMP certificate with no GMP observations to support 100 Mill USD sales
• Provide an reorganizational proposal to improve productivity 5% linked to MBO
• Reliable training matrix to support GMP & operations
  

Sr Operations Director

Responsible of all production sites incl. Biotech & Pharma (5) and leading Operations and supply chain, deploy strategy, compliance of WW health agencies to support sales over 30 countries, procuremet and inventory planing, capital projects execution (>8 mill USD), compliance on EHS rules

Delivered Results:
• Stand Alone project to create a Pkg facility in the FG's warehouse to have a sustainable and flexible Pkg operation, established a new supply concept in the Pharma trends. Approved by MoH and running. to support future launches of ~15 mill USD/yr
• Five facilities construction (in less than a year), (Sterile, OSD and High Potent drugs - Both technologies) Qualification and start up to provide continuity to the business. to protect 90 Mill USD/yr
• Facility shutdown 110 HC reduction and remediation action plan proposal >8 Mio USD on CapEx and supply continuity scheme as distributor license and Third Mfg parties, NO impact to the business, protect 80% of profit 40 Mill USD/yr
• Plant shop floor engineering improvements to increase capacity at the facilities on Cyto - Sterile technology to cover 20 Mill USD on sales and other successful projects implementation based on SIPOC, VSM tools to improve productivity and decision-making process at managerial levels improved Productivity on 5%
• Several successful launches to support diffrent countries (Israel, Mexico, Canada, Europe, Easter Europe and Asian countries) approx 1 Mill USD per product
• Several Successful Inspections from countries (Turkey, Lithuania, Brasil, Europe, Colombia & Mexico)
• Structural Crisis successful management, Quality Lab shutdown and alternative Lab running in 30 days. Protecting 12 mill USD/month
• Implementacion de S&OP meeting & ORACLE,  incremento de nivel de servicio de 50% a 90% en un año.
• Clean industry certificate by Mexican Environmental authorities & Environmental site release closed since 2009 to Sale the site
• S&OP meeting & ORACLE implementation, increase the service level from 50% up to 90% in one year.
• Close-down a Betalactamic site with no supply, personnel (union) and environmental impacts to avoid continuing losses of >750kUSD/yr
• Organizational Turnover (Crisis management) & Swine Flu Crisis management with out impact on supply 12 mill USD/month
  

Operations Director

Responsible of 2 production facilities incl. Milk Mfg & Pharma and leading Operations and supply chain, deploy strategy, compliance of LatAm health agencies to support sales over the region, procuremet and inventory planing, capital projects execution (>4 mill USD), compliance on EHS rules and Cold Chain logistics.

Delivered Results:
• Nutritional Plant refurbishing without supply impact Service level above 98%
• Production of a cold chain product in short term to support the Mexican vaccination program 2009. ~80 Mill USD sales value
• Plant start up after a long shutdown of 3 months (Crisis management), recover a micro contaminated facility to produce ~60 mill USD
• Multivitamin product support and re-supply after a stability OOS (Crisis management) 10 Mill USD/yr 
  

Production Director

Responsible of 2 production facilities Pharma and leading Production and Engineering, execution on Production strategy, compliance of Mexico, Canada and USA health agencies (FDA) to support sales, capital projects execution (>4 mill USD), support compliance on EHS rules.

Delivered Results:
• Overall productivity increase & Capacity utilization increase to save 20 mio MxP and Flexibility labor concept implementation baseline and union managing by objectives implementation creating a window of 30% labor cost reduction.
• Several Cost Savings in Yield of for  4.3 Mio USD & Additional savings from re-structuring the Pharma Production operation and include a Managing by objectives and Bonus system at Union level with an impact of 700 TUSD.
• FDA Post-approval inspection (2007). None 483 issues, 3rd time consecutive no observations from FDA, reaching the sales level of 250 Mill USD/yr on Exports to USA, FDA Post-approval inspection (2004). None 483 issues, 2nd time in a row with no 483 & protecting Health Products and Food Branch Inspectorate (HPFBI) Post-approval inspection. None Critical issues. FDA Pre-approval inspection (1998). None 483 issues & Start up the solids production facility. 80 products, 150 presentations, Restart the Canadian products deliveries. 7 products to support
• Business case to reduce the conversion costs up to 25% in a 1 year period, and team & start up preparation 
• Increase the Operational productivity by merging the Mechanical function in the Pkg lines, increase of 10% and cost reduction of 200 kUSD/yr
• Several Launches and Technical Transfers for Canadian/Mexican/USA markets packaging transferred from Germany & USA. on Global cost savings projects ~20 Mill USD to reach sales of ~100 Mill USD/yr
• Cost Saving Projects $150,000 USD and Cost Avoidance Projects $1’000,000 USD (Tax classification).
• Yields increments in the Solids plant of  $120,000 USD, Cost Saving Projects $300,000 USD
  

Packaging & Production Head

Responsible of all packaging and Mfg activities at San Angel facility Pharma and leading Production and packaging areas, support compliance of Mexico health agencies (COFEPRIS)  and technical transfer execution.

Delivered Results:
• Technical transfer of Packaging, Solids and Injectable product processes (site transfer)
• Plant capacity & shop floor control implementation. BPCS version 4.1  to ensure Plant Capacity managements.
• Financial justification and development to improve the packaging of lyophilized products. providing cost savings of 25kUSD/yr
  

Management & Finantial Advisor,

Responsible of  supporting the management of administrative activities and support the finantial strategy.

Administrative Manager

Responsible of  administrative management 

Production Head

Resposible of production on the Pharmaceutical Mfg and Packaging at 2nd shift and leading Production compliance of Mexico. 

Delivered Results:
• Yields controlling data base development and started up contributing on cost measuring & improvement
• Direct compression development for a multivitamins solid product. cost reduction project of 50kUSD/yr
• Direct compression development for a psychotropic solid product. Cost reduction project of 20kUSD/yr
• Non sterile Process Validation at solids area (A.F.M.)
  

MEXICAN NATIONAL UNIVERSITY, Mexico, Mx

Bachelor of Science, Chemist-Pharmaceutical Biologist

Universidad La Salle, A.C.   "Total Quality"

ITESM "Manager Skills Training".

International Management Development Program Boehringer Ingelheim.

Accelleration Growth Executive Program LatAm Teva.

"Solid Dosage Form Product transfer-Practical Case- Risk Assessment Approach" as poster presenta

Article publication "Raw material contamination a case study" Enrique Blanco, Journal of GXP Co

Delivered Results: