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Formulation Scientist

Location:
United States
Posted:
September 11, 2008

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Resume:

HECTOR MACHADO

**** ********** *****

Kalamazoo, Michigan 49009

Cell 859-***-****

E-mail: ********.*@*******.***

PROFESSIONAL HIGHLIGHTS:

Research & Development Experience:

• Nanotechnology (nano-based delivery systems)

• Polymeric film drug delivery systems (fast dissolving, extended release, mucoadhesive patches)

• Formulation of Sterile intranasal solutions

• Formulation and characterization of nanotechnology based vaccines

• Micro-emulsions and multiple emulsions as precursors for nanoparticles and microspheres

• Micro- and nano-encapsulation technologies

• Pharmaceutical technology (manufacturing process: mixing, drying, granulation, compression)

• Solid, liquid, and semi-solid dosage forms: R&D, scale-up

• Formulation of dosage forms for poorly soluble drugs

• Emulsion technology (the HLB concept to formulate stable emulsions)

• Pharmaceutical excipients (surfactants, antioxidants, preservers, fillers, disintegrants)

• Bioavailability and bioequivalence studies

Management & Leadership Experience:

• Management and coordination of activities of scientists performing preformulation, formulation and scaling up

• Write project plans, communicate with clients and manage work in a timely manner

• Worked in multiple projects and supervised technicians in the implementation of experiments

• Technical presentations of products to support sales

• As part of a team, write CMC section for IND submissions, SOPs and Batch Records

Skill and activities :

• Fluently read, write and speak English and Spanish languages

• Experience in coordination of academic activities

• Computer skills in Window XP, Excel, Office 2000 and Internet.

• Ability to work projects without supervision or as a part of a working team.

• Ability to work in new working environments and with new people.

EMPLOYMENT EXPERIENCE

NANOMED PHARMACEUTICALS INC., Kalamazoo, MI 49009 Nov 2007 – Present

Formulation Scientist

Essential Duties and Responsibilities

• Planning and performing laboratory experiments to develop and optimize formulations and manufacturing processes

• Profiling physico-chemical properties of compounds

• Conducting excipients stabilities

• Planning and excecuting stability studies

• Formulation and development of parenteral dosage forms including solutions suspensions and lyophilized products

• Scientific documentation of lab experiments, data analysis and technical reports writing.

Achievements

As part of the team working in the formulation and development of Solid Lipid

Nanoparticles (SLN) Drug Delivery System, I have contributed to the finding optimization and scaling up of an oncolitic prototype formulation.

WATSON INC., West Haven, CT 06516 April, 2007 – Oct 2007

Drug Delivery Scientist in the Film Technology Division

Essential Duties and Responsibilities

• Develop film prototypes and formulations to meet customer needs

• Prepare materials and to perform laboratory examinations according to customer and sales requirements

• Support sales with technical presentations

Achievements

• Development of several film prototype formulations for customers

• Prototype formulation of a local anesthetic based film dressing, designed for topical release. This project was necessary to support funcional film patent of the company

• CASTABLE PHARMACEUTICAL EDIBLE FILMS Poster presented at the APPS Meeting and Exposition. San Diego, CA. November 11-15, 2007. Authors: Ming J Chen, Gloria Tirol and Charles Bass (The Dow Chemical Company, Bound Brook, NJ) Caroline Corniello, Ivonne Sanchez and Hector Machado (Watson Inc, West Haven CT)

BIODELIVERY SCIENCES INTERNATIONAL (BDSI), Newark, NJ 2004 - 2007

Senior Formulation & Development Scientist

BDSI is a biotechnology company dedicated to the research, development and utilization of a unique and proprietary technology with broad applications for the delivery of drugs and vaccines.

Essential Duties and Responsibilities

• Was responsible for the development of research projects utilizing the new delivery system in the drug delivery area.

• Was responsible for co-designing experiments in coordination with the Executive Vice President.

• Worked on multiple research projects and to supervise technicians in the implementation of experiments.

• Generated reports and to write publications based on the results of various projects.

Achievements

I developed the method and technology to scale-up a proprietary BDSI formulation from a laboratory bench top process to a pilot plan operation. This work has been instrumental in the company’s effort to initiate clinical trials.

CENTER FOR PHARMACEUTICAL SCIENCE 2000 - 2004

AND TECHNOLOGY (CPST),

UNIVERSITY OF KENTUCKY COLLEGE OF PHARMACY,

Formulation Coordinator

The CPST is a FDA-registered GMP pharmaceutical manufacturing and development facility.

Essential Duties and Responsibilities

Was responsible for pre-formulation and formulation development activities including preformulation and formulation efforts, writing SOPs, batch records, technology transfer and scale-up to support GMP manufacturing in the CPST.

Achievements

During the time with the CPST, I worked and finished several formulation and development projects for different national and international pharmaceutical companies including: Nanomed, BDSI, Intranasal Therapeutics, Agennix and National Institute for Biological Standards and Control (NIBSC)

• Formulation of several sterile intranasal formulations

• Optimization of a process to manufacture an anticancer nanosuspension ; technology transfer and scale-up to support GMP manufacturing in the CPST.

• Development and drug release study of an enteric coated capsule containing a lyophilized recombinant protein

• Formulation and characterization of nanotechnology-based vaccines

• Development and scaling-up of a manufacturing process to produce stable oral antifungal nanosuspension.

PHARMACEUTICAL CHEMISTS SOCIETY, Cali, Colombia 1996 - 1999

Chairman of the Development Committee

Organized academic events of the “XXIV meeting of Pharmaceutical Chemists Society”

BAYER COLOMBIA, Cali, Colombia 1989 - 1994

New Product Development Manager (1992 – 1994)

Developed pharmaceutical formulations for new drug compounds; used pharmaceutical and chemical principles to establish the optimum formulation parameters for particular dug compounds (solids, liquids and semisolids); assisted with the technology transfer of methods to the pharmaceutical manufacturing facility.

Production of Solids (1991 – 19992)

Programmed and directed production of tablets, capsules, granules and powders; supervised compliance with cGMP and kept production and control records; wrote official product documentation to regulatory offices.

Technical Director Assistant (1989 – 19991)

Assisted the Technical Director in the preparation of documentation for local and parent company regulatory submissions; supervised laboratory team concerning analytical tests on existing and new pharmaceuticals, and generated stability and control data. Wrote SOP and technical reports and submitted projects for new product development and modified or adapted formulations to regional market necessities; coordinated all activities related with validation of manufacturing areas, equipment and processes; participated in scientific meetings; presented analytical and technical data and assisted in the writing of new projects.

FERTILIZANTES Y PLAGUICIDAS DEL VALLE, 1987 - 1988

Ginebra, Colombia

Technical Director

Programmed and directed production of fertilizers and plague control solutions; supervised compliance with Current Good Manufacturing Practices (cGMP) and kept production and control records; wrote all official product documentation to Colombian regulatory offices; formulated and developed new products.

UNIVERSITY OF ANTIOQUIA, 1972 - 1987

COLLEGE OF PHARMACY, Medellin, Colombia

Faculty in the Pharmacy Department

As a member of the faculty, I taught the following courses:

Pharmaceutical Technology I Solids: Tablets, Capsules, Powders, Granules with lab practices

Pharmaceutical Technology II (Liquids): Sterile (parenterals, intranasals, large volume parenterals). Non-sterile: (syrups, suspensions, emulsions, creams) with lab practices.

Biopharmaceutics and Pharmacokinetics (ADME process)

Assisted the students in their academic work; graded exams and reports and participated with other faculty in research activities.

• Associate Dean of the College of Pharmacy, April 1978 to February 1980.

Assisted the Dean to coordinate all academic activities

• Chairman of the Pharmacy Department, April 1982 to November 1983

Coordinated the academic activities of the department and represented it in academic and administrative meetings.

MCKESSON (Pharmaceutical Generic Products ) Jan 1971 – Dec 1971

Bogota, Colombia

Manager of the Parenteral Department

Programmed and directed production of parenterals.

Analyst in the QC Department

Performed, developed and validated analytical assays for pharmaceutical products.

EDUCATION

Post-graduate Specialization in Pharmaceutical Technology, August 1986

University of Ghent, College of Pharmacy, Ghent, Belgium, sponsored by the United Nations Industrial Organization (UNIDO) and the World Health Organization (WHO).

M.S. in Pharmaceutical Sciences, June 1976

University of Kentucky, College of Pharmacy, Lexington, Kentucky under the direction of Patrick P. DeLuca Ph. D..

B.S. in Pharmaceutical Chemistry, December 1970

University of Antioquia, College of Pharmacy, Medellin, Colombia

HONORS, AWARDS, AND DISTINCTIONS

• WHO-UNIDO- Belgium Government Scholarship, Ghent, Belgium.1986.

• Titular Professor, University of Antioquia, Medellin Colombia 1985.

• Visiting Professor, University of Cartagena, Cartagena Colombia 1979.

• LASPAU Scholarship, USA Government, 1975.

• Pharmaceutical Chemist of the Year, 2000 (Granted by the Pharmaceutical Chemist society of Colombia).

PUBLICATIONS

CASTABLE PHARMACEUTICAL EDIBLE FILMS Poster presented at the APPS Meeting and Exposition. San Diego, CA. November 11-15, 2007. Authors: Ming J Chen, Gloria Tirol and Charles Bass (The Dow Chemical Company, Bound Brook, NJ) Caroline Corniello, Ivonne Sanchez and Hector Machado (Watson Inc, West Haven CT)

ORAL DELIVERY OF AMPHTERICIN B COCHLEATES: DEVELOPMENTAL STATUS Poster presented at the Annual Focus on Fungal Infections 14 Meeting. New Orleans March 24-26, 2004, Authors: Patrick L. Ahl, David Delmarre, Joel Ngoje, Feng Tan, Ruying Lu, Jessica Sandulow, Suraj Kalbag, Susan Gould Fogerite and Raphael J. Mannino(BioDelivery Sciences International, Inc., Newark, NJ ) Hector Machado, Russell Mumper, (Center for Pharmaceutical Science and Technology, University of Kentucky, Lexington KY)

SCALE-UP OF AN ORAL AMPHOTERICIN B PHOSPHATIDILSERINE COCHLEATE FORMULATION Poster presented at the 2004 AAPS National Biotechnology Conference May 16-19; The Westin Copley Place Boston, MA. Authors: Patrick L. Ahl, Susan Gould Fogerite, Joel Ngoje, Feng Tan, Suraj Kalbag and Raphael J. Mannino (BioDelivery Sciences International, Inc., Newark, NJ ) Hector Machado, (Center for Pharmaceutical Science and Technology, (University of Kentucky, Lexington KY)

NEW DEVELOPMENT IN COCHLEATES DELIVERY TECHNOLOGY Poster presented at the Controlled Release Society (CRS)2004, 31 Annual Meeting & Exposition June 12-16, 2004 Honolulu, Hawaii, USA Autors:David Delmarre, Patrick Ahl, Stephane Allard, Susan Bonitz, Zi-Wei Chen, Susan Gould Fogerite,Yuqing Guo, Suraj Kalbag Sara Krause-Elsmore, Ruying Lu, Palma Ann Marone,Joel Ngoje Jessica Sandulow, Feng Tan , Raphael J. Mannino (BioDelivery Sciences International, Inc., Newark, NJ ). Hector Machado, Russell Mumper (Center for Pharmaceutical Science and Technology, University of Kentucky, Lexington, KY) Guillaume Delmas and David Perlin (Public Health Research Institute at the International Center for Public Health, Newark,NJ)

COCLEATE DELIVERY TECHNOLOGY: RECENT DEVELOPMENTS IN ORAL DELIVERY OF AMPHOTERICIN B Poster presented at the AAPS Annual meeting, Nov. 7-11 2004 Baltimore, USA Autors: Suraj Kalbag, Patrick Ahl, David Delmarre, Susan Gould Fogerite, P Marone, Sara Krause-Elsmore, Joel Ngoje Ruying Lu, Jessica Sandulow, Raphael J. Mannino (BioDelivery Sciences International, Inc., Newark, NJ ). Hector Machado, Russell Mumper (Center for Pharmaceutical Science and Technology, University of Kentucky, Lexington, KY) Guillaume Delmas, S Park and David Perlin (Public Health Research Institute at the International Center for Public Health, Newark,NJ)

EFFECT OF SCALE UP AND PARTICLE SIZE ON THE ORAL EFFICACY OF A SOY PS COCHLEATE FORMULATION OF AMPHOTERICIN B P. Ahl, D. Delmarre, H. Machado, J. Ngoje, F. Tan, R. Lu, J. Sandulow, S. Kalbag, P. Marone, S. Krause-Elsmore, S. Gould-Fogerite & R. Mannino.( BioDelivery Sciences International, 4 Bruce Street,Newark, NJ 07103, USA), G. Delmas, D. Perlin(Public Health Research Institute, Newark, NJ 07103)

NANOTECHNOLOGY, THE SCIENTIFIC AND INDUSTRIAL REVOLUTION OF THE 21 ST CENTURY Hector Mahado, “Actualidad “ , Vol 1 No 3 – 2004, Di-graphics LLC 1412 Village Dr. Lexington Ky 40504

ETERNAL YOUTH Hector Machado, “Actualidad “ , Vol 1 No 5 – 2004, Di-graphics LLC 1412 Village Dr. Lexington Ky 40504

INTELLECTUAL PROPERTIES

Aqueous Formulation of Tetra-hydrocannabinol and Derivatives for Intranasal Administration. Inventors: Daniel Wermeling Pharm. D., Hector Machado M.S., and Michael Jay Ph. D.. Submitted to University of Kentucky Research Foundation

The invention described in the intellectual property disclosure involves the development of an aqueous –based formulation containing 1-Trans-delta -9-tetrahydrocannabinol (THC) suitable for administration in a unit dose nasal spray device.

REFERENCES

Russell J. Mumper, Ph.D.

John A. McNeill Distinguished Professor

Director, Center for Nanotechnology in Drug Delivery

University of North Carolina at Chapel Hill

E-mail: ******@*****.***.***

Phone: 919-***-****

Fax: 919-***-****

Cell: 919-***-****

Raphael Mannino, Ph. D.

Chief Scientific Officer & Executive Vice President

Biodelivery Sciences International

185 South Orange Ave. Adm. Bldg # 4

Newark, NJ 07103

Tel 973-***-****

Patrick P DeLuca, Ph.D.

Syllivan Medallist

Proffessor

University of Kentucky

College of Pharmacy

Lexington, KY 40506

Tel 859-***-****

Email: *******@*****.***.***



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