CARLOS ALVAREZ SALGUEIRO

Victor Hugo ***

Col. Jardines Universidad

Zapopan, Jalisco 45110 Mexico

Phone: 333*******/Cel: 334*********

E-mail: r5nzvy@r.postjobfree.com

Objective

I am a highly self-motivated and results-oriented professional committed to pursuing a long-term career in a business-related or manufacturing field that will enable me to use my strong organizational skills, educational background, and ability to work well with people.

Qualifications Summary

Offer a solid17-year track record demonstrating strong analytical, problem solving, and relationship-management skills with considerable experience in the food, pharmaceuticals, and consumer healthcare industries. Proven relationship-builder with unsurpassed interpersonal skills. Flexible team player who thrives in environments requiring ability to effectively prioritize and juggle multiple concurrent projects. Personable professional possessing cultural sensitivity and an ability to build rapport with a diverse workforce in multicultural settings. Able to travel as needed.

Key strengths and competencies:

Experience in Academics

International experience in Supply Chain Quality (Europe)

Quality Oversight of Contract Manufacturing Organizations

Quality Assurance and GMP/USFDA compliance

Process technology transfer and validation

Process Automation via PLC and DCS control systems

Installation, startup and upgrades of various systems

Design of chemical manufacturing facilities

Design of bulk pharmaceutical pilot plants

Quality Systems development and implementation

Team Leadership, Coaching, and Mentoring

Food products/process development

Validation of biotech facilities and computerized systems

Highly adaptable, mobile, positive, resilient, patient risk-taker who is open to new ideas

Energetic performer consistently cited for unbridled passion for work, sunny disposition, and upbeat, positive attitude

Enthusiastic, knowledge-hungry learner, eager to meet challenges and quickly assimilate new concepts

Professional Experience

Universidad Autónoma de Guadalajara, Jalisco, México

Department of Design, Science and Technology

Masters of Quality Systems

Professor – Costs of Quality August 2011 – December 2011

The course was intended to teach the students how to develop the skills to identify and calculate the costs of prevention and correction of non-conforming products, which are key elements of total quality management. Taught the various categories of costs of quality with the objective of determining an adequate structure of a cost of quality system (COQ). Taught how to utilize a COQ to justify and support quality improvement in the main areas of activity related to product manufacturing and services provided.

I also taught a course in Total Quality Management at the Bachelor’s level to teach the students the integrative philosophy of management for continuously improving the quality of products and processes, which includes the utilization of quality tools and methodologies such as Six Sigma, Lean Manufacturing, process variability and control, benchmarking and process reengineering.

Biogen Idec International GmbH, Zug, Switzerland (International Headquarters)

Global Quality Operations

Associate Director - Supply Chain Quality for June 2010 – June 2011

European Union & Rest of the World

Provided support for PAI readiness and manufacturing launches for critical products. Responsible for supporting pre launch efforts for various medical devices programs. Supported the manufacturing plans for multi-site clinical and commercial campaigns, and ongoing stability studies. Responsible for communicating quality issues and metrics to senior management. Participated in cross-functional teams with Planning, International Logistics, Packaging, Contract Manufacturing, Technical Development, Quality Control, Quality Assurance, Regulatory Affairs, and Drug Safety and Risk Management. Responsible for development and negotiating Quality Agreements with CMO’s and corporate partners. Provide support for manufacturing deviations, change control, investigations in Trackwise, reviewing regulatory submissions prior to agency submission, and reviewing technical product complaints from international consumers. Responsible for developing and maintaining strong relationships with contractors and corporate partners. Participated in Biogen Idec audits of CMO’s and supported Health Authority audits at contract sites. Responsible for approving validation protocols and reports. Responsible for providing clear and visible roles and responsibilities, setting clear performance expectations and ensuring metrics are aligned with business needs. Supported CMC schedules for regulatory submission of Biogen Idec priority programs according to established timelines. Responsible for managing the training coordinator role for Supply Chain Quality. Provided quality support for the review and approval of shipping qualification for existing and new shippers and/or lanes, and review Logistics procedures.

Key Projects and Achievements:

• Successfully managed the Supply Chain Quality team of 8 people supporting the development, manufacturing, packaging and transportation of product manufactured at CMOs for the European Union & Rest of The World markets.

• Supported transfer of QA disposition responsibilities for commercial large and small molecules from International QA to my group in Switzerland.

• Responsible for providing quality support for small molecule API/DP and large molecule DP manufacture for 11 clinical and 4 commercial products manufactured at Contract Manufacturing Organizations (CMOs) in EU and ROW markets and distribution to warehouses.

• Supported transfer of QA approval responsibilities for deviations, change control, and CAPAs from International QA to my group and greatly improved overall Trackwise metrics related to CMO’s.

• Supported supply chain quality improvements (i.e. report standardization, Quality Management reviews) and ensured continued supply of product and avoided product stock outs.

• Supported phase-appropriate systems that allow processes and procedures designed around clinical and commercial manufacturing.

Bristol-Myers Squibb, New Brunswick, NJ

Research & Development – Pharmaceutical Quality & Environmental, Health and Safety

Manager – Quality Systems, Global Process and Procedural Management April 2009 – May 2010

Responsible for managing Pharmaceutical Development level documents throughout their lifecycle of authoring, initial review and approval, impact assessment, periodic review, and revisions as applicable. Served as project manager to Biopharmaceutics and Process Research & Development SOP teams, working closely with the functional area SOP team leader and preparing meeting agendas, minutes, and action item lists, and providing consistent direction regarding the Pharmaceutical Development document management process and associated quality standards. Developed defensible risk based approaches to procedure management and quality related processes such as TSE Risk Assessment. Supported continuous improvement of Pharmaceutical Development GMP processes through innovation in documentation and implementation of quality related processes that maintain or enhance compliance. Acted as the EPIC STAR Superuser and Leader of Pharmaceutical Development EPIC STAR Content Manager Community. Responsible for creating and maintaining user guides for the departmental document management processes and EPIC STAR to assure compliant and productive use of EPIC STAR. Responsible for delivering progress and metrics reports to upper management on a frequent basis and represented the department in various divisional and corporate initiatives.

Key Projects and Achievements:

• Employed methods to rationalize and optimize the functional area procedural document inventory by aligning and consolidating functional area SOP procedural documents to support the goal of reducing the Pharmaceutical Development procedural document inventory 10% every year for 3 years.

• Responsible for assessing materials used in the manufacturing of more than 50 batches of small molecule API and Drug Product for Transmissible Spongiform Encephalopathy (TSE) risk.

• Prepared analysis of the current API and Drug Product TSE assessment processes and identified recommendations for continuous process improvements to support the company’s Productivity Transformation initiative for driving productivity and efficient allocation of resources to reduce cycle time and costs.

• Held quarterly EPIC STAR forums, assessed and introduced new EPIC STAR functionalities to the Pharmaceutical Development content managers.

Bristol-Myers Squibb, Hopewell, NJ

Research & Development – Protein Therapeutics Development

Manager – Protein Therapeutics Development Operations June 2006 – March 2009

Responsible for providing compliance and direction in a Protein Therapeutics Development environment. Managed, established and implemented documentation and control programs such as Environmental Monitoring. Responsible for the critical interfaces with Quality and Global Compliance groups to audit, validate and release Phase I and Phase II manufactured products. This position required knowledge of quality system development and implementation, process development and implementation for change control, corrective and preventive action and measurement systems. Demonstrated ability to work with and manage direct reports and consultants in a complex, changing environment to deliver on project commitments and fulfill departmental goals. Responsible for delivering progress and metrics reports to upper management on a monthly basis and represented the department in various divisional and corporate initiatives. Responsible for overall departmental audit readiness and quality and compliance support for programs such as training, procedural documentation, and calibration/Preventive Maintenance.

Key Projects and Achievements:

• Responsible for supervising the validation program and modifying the current change control program for the Protein Therapeutics development laboratories and BioAnalytical Sciences equipment and PC driven laboratory instrumentation.

• Brought over 150 standard operating procedures into compliance with divisional and corporate directives within 2 years.

• Operations and document control main support for two internal GMP/GLP audits and one external GMP audit.

• Handled a substantial amount of audit observations and implementation of corrective/preventive actions (CAPAs) through the Trackwise system as well as participating in identifying quality events and conducting quality investigations.

Bristol-Myers Squibb, New Brunswick, NJ

Worldwide Quality and Compliance – Technical Operations

Associate Manager – Manufacturing Change Control December 2004 – May 2006

Responsible for supporting the global manufacturing change management program and for providing oversight and guidance to change control activities and practices to assure an efficient system is maintained and timely customer services is provided. Interface with the BMS Pharmaceutical Research Institute, Technical Operations, BMS Business Partners, Divestitures, Third Party Sales, raw material suppliers, and worldwide third party manufacturers to coordinate and resolve issues related to change control requests which involve products of various dosage forms. Participate in change control strategy meetings to coordinate the review and approval of changes involving multiple sites and products. Built a strong network of contacts throughout the organization (Global Regulatory, Global Supply Chain, Manufacturing Technology, Worldwide Quality & Compliance, Analytical Development, Worldwide Packaging Technologies, Manufacturing Sourcing & Strategies, EH&S, Third Party Sales, Global Strategic Sourcing, and worldwide manufacturing sites to ensure that change control activities were are aligned with organizational objectives and compliance and regulatory requirements.

Key Projects and Achievements:

• Established requirements and expectations for a consistent Qualified Persons (QP) notification system for significant changes including manufacturing, Global Testing Standards, and packaging components.

• Established a formal change control notification system between BMS and key business partners and key third party manufacturers.

• Supported BMS Technical Operations network optimization strategies and supported the Mead Johnson Nutritionals Pediatric Vitamins outsourcing initiative.

Bristol-Myers Squibb, New Brunswick, NJ

Quality Assurance & GMP Compliance Specialist September 2002 – November 2004

Process Research & Development Operations Engineer June 2001 – August 2002

Responsible in providing quality assurance and GMP compliance for validation projects in API Process Research & Development, Clinical Supply Operations, and Protein Therapeutics development, including equipment, facilities, and DCS process control systems. Provide assurance that CFR 21 Part 11 guidelines are followed when using computerized systems. Worked on the installation/validation/startup of a Filter Dryer, Extract Glove Box, and a Conical Dryer for medium scale pilot plants. Worked in equipment factory testing for a large scale, state-of-the-art pilot plant and prepared related validation documentation. Designed protocols and tested flexible containment enclosures for solids containment.

Key projects:

• GMP Compliance and QA support for a $150 million large scale chemical organics facility

• GMP compliance and QA support for a $20 million protein therapeutics process development facility

• Change control management lead

• QA support for major computer system rollouts (SAP, Plant Information PI)

Foster Wheeler USA Corporation, Clinton, NJ

Process/Project Engineer August 1996 - May 2001

Employed as a process engineer in the Pharmaceuticals and Life Sciences Division and provided on site professional services (engineering and project management) for the following companies:

Bristol-Myers Squibb- New Jersey (October 2000 – May 2001)

Block Drugs Corporation – Puerto Rico (January 2000 – September 2000)

Warner-Lambert – Pennsylvania (June 1998 – December 1999)

Block Drugs Corporation – Puerto Rico (November 1997 – May 1998)

Key Projects and Achievements:

• Provided engineering recommendations for upgrading a major nitrogen system and USP water system.

• Installed a robust PLC based control system for consumer healthcare manufacturing processes.

• Involved in the technology transfer of consumer products from a major US company to contract manufacturers in the United States & Canada.

• Involved in the startup and validation of utilities and manufacturing processes for a major consumer healthcare company.

• Worked in the Conceptual Design for a flavors/fragrances chemical manufacturing facility based in China. Included batch reactions, distillation, hydrogenation and continuous catalytic reactions and utilities.

• Worked in the Preliminary Design of a Multipurpose Pharmaceutical Pilot Plant based in Taiwan. Included reaction modules, filters/dryers, distillation, ion-exchange and extraction modules, purification, final packaging modules, support facilities and utilities.

• Involved in the Conceptual Design of a Large Scale Organics (LSO) Pilot Plant for a major pharmaceutical company (Merck).

• Assisted in the Detailed Engineering for an expansion of a Bulk Pharmaceutical Pilot Plant in New York (Wyeth-Ayerst Lederle Laboratories).

Nabisco, Inc., East Hanover, NJ

Process Engineering October 1994 - August 1996

Process Engineer Intern/Coop 1992 & 1993

Key Projects and Achievements:

• Developed project plans and resource allocation for capital projects in a manufacturing plant.

• Provided engineering and process development expertise toward resolving food product functionality/consistency problem. Responsible for the identification and optimization of an improved, controllable and reproducible food production process.

• Installed and provided assistance in the start-up, commissioning/optimization, training sessions, and product trials for a new Bulk Fermentation System Expansion at the Fairlawn, NJ Bakery.

• Developed a rapid NMR Standard Addition Test and a Methylene Chloride Solvent Extraction System Test for fat and moisture analysis; test calibration procedures by DSC data, and used Infrared Spectroscopy for foreign material identification on food products to improve quality control laboratory testing methods.

Exxon Chemical Company, Linden, NJ

Process Engineer Intern 1990 & 1991

• Performed inclined panel deposit tests for evaluating effects of carbon deposits on engine performance.

• Developed computerized experiments, test methods and conducting rust and oxidation tests.

Education

BS, Chemical Engineering, University of Puerto Rico, Mayaguez, Puerto Rico 1994

Masters Business Administration, Rider University, Lawrenceville, NJ 2002

Skills

Computer-literate performer with extensive software proficiency covering wide variety of applications (i.e. Extensive use of Microsoft Office applications)

Use of DreamWeaver and SAP

Exceptional listener and communicator who effectively conveys information verbally and in writing

Fully bilingual (English/Spanish)

Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work

processes

Resourceful team player who excels at building trusting relationships with customers and colleagues

Strong decision making and problem solving skills

Memberships and Associations

Member of Beta Gamma Sigma (National Business Honor Society)

Member of Tau Beta Pi (National Engineering Honor Society)

Member of American Institute of Chemical Engineers

Member of the Society of Hispanic Professional Engineers (SHPE)

Sergeant-At-Arms of the BMS – New Brunswick Toastmasters Club

Member of Unidad Hispana (BMS Employee Resource Group)

INROADS Alumni

Achievements

Engineer in Training (EIT) Certificate

Exxon scholarship for Achievement

INROADS Achievement awards

Block Drugs Award for Professional Accomplishment

Bristol-Myers Squibb Triumph Award

Professional Development

4-year Instructor - Presidential Classroom’s in Washington D.C

Management Laboratory for High Potential Managers

AMA - Managerial Skills of Prospective Managers

INROADS Professional Development Workshops

Time Management & Project Management workshops

Project Team Leader Workshops

NJ Pharmaceutical QC Association Certification

Delta V Distributed Control System training

BMS Leadership training for high potential Hispanic managers

BMS Connections Mentoring Program (Mentor)

Pharmaceutical Law and Administration course sponsored by DBA

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