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 Expert  724282

Expert in Production and Design of Pharmaceutical Products


Available for your Consulting and Expert Witness Needs

Mexico City
Mexico
Education Work History Career Accomplishments Consulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
Expert Nowaday is working as R&D and QC manager in a pesticides and biopesticides industry. He has 11 years of experience on development and transfer of new pharmaceutical products from R&D into manufacturing. He developed pharmaceutical products as softgel (nutraceuticals, supplements, OTC's, enterics), softlets, tablets, ophthalmics solutions, syrups, injections, ointments and he has knowledge about chewable softgels, non-animal gelatin, controlled release. And developed pesticides and biopesticides products.

He has been responsible to leading, training and developing R&D and QC chemists as Manager and Head of formulations and operation people as Head of Production as well as leading R&D projects as planning coordinator. He has knowledage of regulatory requirements (cGMP's, safety, and environment).

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chemical process control

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design process

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drug labeling requirement

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industry standard

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international standard

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new product design

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new product development

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pharmaceutical product development

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pharmaceutical quality control

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product design

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quality auditing


Show Secondary and Basic Areas of Expertise

Often requested
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Pharmaceutical Solid Dose Forms
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Education:
Year   Degree   Subject   Institution  
2004   Master of Administation   Industrial   National Autonomus of Mexico University  
2000   BS   Chemist on Pharmaceutical and Biological Sciences   National Autonomus of Mexico University  

Work History:
Years   Employer   Department   Title   Responsibilities

2007 to 2008

 

Tecnofarma

 

R&D

 

Head of Formulations and Planning Coordinator

 

As Head of Formulations, he had Participated in each step of new product development and their technology transfer into manufacturing. He had been involved in internal and external audits in order to verify the cGMP's accomplishment. He gave technical support to internal and external customers. (Troubleshootings) in order to cover requirements and customer expectations. He had collaborated with other areas to ensure that each program (R&D projects, transfer program, quality programs, etc) achieved milestones. He designed batch paperwork, test protocols, technical reports, formats, SOP's (standard operating procedures), specifications, and operating procedures. He hired and trained R&D chemists.

As Planning Coordinator of R&D, he had implemented a pharmaceutical development system to cover each step on time (factibility, preformulation, formulation, lab batches, stability studies, clinical trials, bioequivalence studies, dossiers integration, scale up, transfer and validation process). He gave technical support to internal and external customers. (Troubleshootings) in order to cover requirements and customer expectations. He had collaborated with other areas to ensure that each program (R&D projects, transfer program, quality programs, etc) achieved milestones.

2001 to 2007

 

Banner Mexico

 

R&D and Production

 

Head of Formulations and Head of Production

 

He understands how to manage a manufacturing shift and their manufacturing schedule. He had participated in technology transfer into manufacturing. He had been involved on internal and external audits in order to verify the cGMP's accomplishment. He had participated on global teams to get commodities for all facilities as expert supporting purchasing. He gave technical support to internal and external customers. He had collaborated with other areas to ensure that all programs achieve milestones. He designed batch paperwork, test protocols, technical reports, formats, SOP's (standard operating procedures), specifications, and operating procedures. He hired and trained manufacturing operator.

As Head of Formulations He had Participated in each step of new product development and their technology transfer into manufacturing. Due to his experience, He had been involved on internal and external audits in order to verify the cGMP's accomplishment. He had Participated on global teams to get commodities for all facilities as expert supporting Purchising. He gave technical support to internal and external customers. (Troubleshootings) in order to cover requirements and customer expectations. He had implemented a pharmaceutical development system to cover each step on time (factibility, preformulation, formulation, lab batches, stability studies, clinical trials, bioequivalence studies, dossiers integration, scale up, transfer and validation process) He had collaborated with other areas to ensure that each program (R&D projects, transfer program, quality programs, etc) achieves milestones. He designed batch paperwork, test protocols, technical reports, formats, SOP's (standard operating procedures), specifications, and operating procedures. He hired and trained R&D chemists, and designed new facilities to R&D.

1998 to 2001

 

ICN Pharmaceutical

 

R&D

 

R&D Chemist

 

He had Participated on new product development, technology transfer into manufacturing and their validation process. He had been involved on internal audits in order to verify the cGMP's accomplishment. He managed R&D warehouse and implementing an electronic control system for raw materials . He gave technical support to internal and external customers. (Troubleshootings) in order to cover requirements and customer expectations. He had collaborated with other areas to ensure that each program (R&D projects, transfer program, quality programs, etc) achieves milestones. He designed batch paperwork, test protocols, technical reports, formats, SOP's (standard operating procedures), specifications, and operating procedures.

2008 to 2009

 

Laboratorios Dermatológicos Darier

 

Validation

 

Head od Technology Transfer

 

He had participated in technology transfer into manufacturing, gave technical support to solve troubleshootings, and designed test protocols, technical reports, formats, SOP's, specifications, and operating procedures.

2009 to

 

Agroquímicos Versa

 

QC and R&D

 

QC and R&D Manager

 

He had participated in planning, design and start-up of bio-pesticide facility, and has lead R&D and QC projects for pesticide facility.


Career Accomplishments:
Licenses/Certifications

Lead audit ISO 9001:2000


Consulting Services:
Recent Client Requests:
  • Intota expert services for consulting on soft-gelatin capsules.
  • Gelatin chemistry expert for consulting on Gelatin injection molding.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
2005 to 2005   USA/North Carolina   • Banner Softgel University (BSU) was provided which includes relevant literatures and internal presentation regarding gelatin, fill compounding, softgel manufacturing process and final commercial aspect of the dosage form. • Observed, participated and contributed during the pilot run for standardized horse chestnut seed extract enteric capsules. Three pilot scale (~55,000 capsules) batches were manufactured. Expert was involved in review of batch paper work, fill compounding, enteric gel manufacturing, encapsulation, drying process and final inspection of these batches. • He has been exposed to development process of new product right from API sourcing to commercial aspects including filing details (Presented by Xiaodi Guo) • Expert was exposed to SoftletTM theoretical aspect of tooling and also demonstrated the SoftletTM run (Supervised by Frank Fox) • He was also introduced to the theoretical aspect of EnteriCareTM (enteric softgel), ChewelsTM (chewable softcaps), EcoCapsTM (non-animal softgels) and VersatrolTM (extended release softgels) • He was also exposed to the ChewelsTM gel manufacturing and encapsulation process for DHA bubble gum flavored product (Supervised by Hassen Nasri) • He was also introduced to the EcoCapsTM for a nutritional product, including gel-manufacturing, extrusion technology and further encapsulation • He was briefed about NP tool software for nutritional related formulation development and costing evaluation (Supervised by Dilip Shah) • He presented the Mexican Ibuprofen formulation as part of redevelopment attempt initiated by High Point and also he was briefed about the path forward activities in the Ibuprofen project • He was exposed to Application lab activities and got hands-on experience on how to run a batch • He was also briefed about reviewing bio-equivalency data (rationale and post analysis) and regulatory filing strategies • He was briefed about Scale-up / Optimization and Tech-transfer requirement for a typical product • He was also briefed about formulation development / approaches of a pharmaceutical solution (Ibuprofen) formulation and suspension formulation (Progesterone) • He attended CPKelco technical meeting for sourcing natural hydrocolloids (such as pectin, carragenan, gellan gum and so on) • He attended R&D quarterly meeting and formulation group meeting • He was trained in USP enteric dissolution method for EnteriCareTM softgels (e.g. Pectin based softgels) • He was also trained in USP enteric disintegration method for EnteriCareTM Softgels (e.g. Horse chestnut seed extract) • He will be briefed about Banner's IDR process and Patent aspect of an innovation

Language Skills:
Foreign Language  
Spanish  
English  

Additional Skills and Services:
Other Skills and Services

1. I speak fluently in English, both written and oral and Spanish (maternal language) 2. I can read, and interpret both business and technical correspondences. 3. I can write technical reports, business memorandum, and SOP's. 4. I understand how negotiate effectively with management, peers, and operators PC skills, including ability to use Microsoft Office Tools, e-mail, e-calendar, PC applications as Windows XP, Aspel, Docal, Dbase III plus, graficación, Microsoft Office, Norton Commander, Internet Explorer. Lotus Smart Suite, Corel Wordperfect Suite 8, AS-400. 5. •Office, lab and production equipment


 

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