Expert Details

Expert in Production and Design of Pharmaceutical Products

Expert ID: 724282 Mexico

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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).


Education

Year Degree Subject Institution
Year: 2004 Degree: Master of Administation Subject: Industrial Institution: National Autonomus of Mexico University
Year: 2000 Degree: BS Subject: Chemist on Pharmaceutical and Biological Sciences Institution: National Autonomus of Mexico University

Work History

Years Employer Title Department Responsibilities
Years: 2007 to 2008 Employer: Tecnofarma Title: Head of Formulations and Planning Coordinator Department: R&D Responsibilities: 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.
Years: 2001 to 2007 Employer: Banner Mexico Title: Head of Formulations and Head of Production Department: R&D and Production Responsibilities: 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.
Years: 1998 to 2001 Employer: ICN Pharmaceutical Title: R&D Chemist Department: R&D Responsibilities: 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.
Years: 2008 to 2009 Employer: Laboratorios Dermatológicos Darier Title: Head od Technology Transfer Department: Validation Responsibilities: 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.
Years: 2009 to Present Employer: Undisclosed Title: QC and R&D Manager Department: QC and R&D Responsibilities: He had participated in planning, design and start-up of bio-pesticide facility, and has lead R&D and QC projects for pesticide facility.

International Experience

Years Country / Region Summary
Years: 2005 to 2005 Country / Region: USA/North Carolina Summary: • 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

Language Proficiency
Spanish
English

Fields of Expertise

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