Expert Details
Production and Design of Pharmaceutical Products
ID: 724282
Mexico
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 |
|---|---|---|---|
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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Fields of Expertise
chemical process control, design process, drug labeling requirement, industry standard, international standard, new product design, new product development, pharmaceutical product development, pharmaceutical quality control, product design, quality auditing, design to capacity, ISO 14000 Environmental Management Standard, ISO 9000-3, quality evaluation, ISO 9000 series quality system standard, ISO standard, microbial control product development, design-for-quality, quality standard, material product development, process design, design for manufacturability, design for testability, quality control, materials standard