Isolina Romero

I'm pharmaceutical chemist and biologist with experience in pharmaceutical development, technology transfer, process validation, process quality control, physicochemical analysis, quality inspection for product release and statistical analysis for continuous process improvement.

Technical assistance - Ultra Laboratorios

(2025-12)

• Evaluation of alternative manufacturers
• Technology Transfer
• process optimization
• Preparation of official document

Pharmaceutical Development - VANQUISH Pharmaceutical

(2024-10 - 2025-10)

Evaluation of alternative manufacturers, new product development, Technology Transfer, process optimization, Unit operations, product inspection for any defects, Good Manufacturing practices, pharmaceutical development protocol, identification and quantification of chemical compounds for pharmaceutical development, Technology Transfer Protocol, Preparation of official document.

• Losartan 50mg tablet reformulation (Finished)
• Sitagliptin (New development Finished)

Validation chemist - AMSA

(2024-02 - 2024-05)

Qualification of production plant equipment, Calibration and metrology reporting, use of ANSI, military standar and AQL tables in quality control.

• Maintenance to validated status (Temporary project for GMP)

Data Analyst - ATRAMAT

(2023-10 - 2024-01)

• Elaboration of clinical database (Temporary Project)

Optimization Engineer - Landsteiner Scientific

(2022-08 - 2022-12)

Evaluation of alternative manufacturers of inputs and excipients Elaboration of protocols and reports from alternative manufacturers Identification of non-conformities in the process fabrication Elaboration of documents for dossier

• Optimization process of metformin 500 mg tablet

Pharmaceutical Development - Sanfer Laboratories

(2021-08 - 2022-04)

Pharmaceutical development and technology transfer, In – process inspection of quality attributes, In-process control verification, identification of chemical compounds for pharmaceutical development, Evaluation of alternative manufacturers, Preparation of official document.

• Pharmaceutical development and technology transfer of Laxoya Tablet 50.0 mg /8.6 mg (star nutraceutical)

Pharmaceutical Development - Drugs Continentales

(2020-12 - 2021-08)

Preparation of SOPS, official documentation, protocols, quality and process reports, making quality inspection in process, technical support to plant, inspection of inputs, intermediate product and finished product, issue process control report, use of ANSI, military standar and AQL tables in quality control.

• Elaboration of SOPS for technology transfer

Interviewer population sensing - INEGI

(2020-03 - 2020-03)

• Population count

Pharmaceutical Development - MAVI FARMACÉUTICA

(2017-10 - 2019-02)

Research and development of generic drugs, elaboration of protocols and reports, In-process quality control verification, inspection of inputs, intermediate and finished products, inspection of quality attributes, Inspect product quality during manufacturing, issue product quality release report, use of ANSI, military standar and AQL tables in quality control.

• Pharmaceutical development of Almagate suspension and chewable tablet

Technology transfer Engineer & Process validation engineer - Landstainer Scientific

(2013-07 - 2017-01)

Validation of process, elaboration of protocols and validation reports Quality inspection process, technology transfer, elaboration of protocols and reports of technology transfer, elaboration of SOPS, physicochemical analysis of product, use of ANSI, military standar and AQL tables in quality control.

• Transfer of processes for opening of new manufacturing plant

Validation training - ASOFARMA DE MÉXICO

(2012-02 - 2013-02)

Equipment and instrument calibration follow-Up with calibration program, elaboration of protocols and equipment qualification reports, validation of hormonal process, elaboration of SOPS and official documentation, In-process quality inspection.

• Qualification of sachet machine (DQ, IQ, OQ and PQ)

Organic chemistry training - Chemistry Institute UNAM

(2009-04 - 2010-04)

Asymmetric synthesis and molecular interaction Synthesis of ferrocenic compounds with catalytic activity Analytical quantification by column chromatography Identification of compounds by infrared spectroscopy

• Experience in instrumental analysis for the synthesis, identification and quantification of organic and inorganic compounds

Diploma - Clinical research - UNAM (2025 - 2025)

Diploma - Effective Project Management - UNAM (2025 - 2025)

Bachelor's degree - Pharmaceutical Chemistry and Biology - FES Zaragoza UNAM

Clinical laboratory technician - CBTis 194