Ana Guadalupe Hernández Acevedo
Azcapotzalco, Mexico City
Summary
M.Sc. in Biochemical Engineering with 15 years of experience in the pharmaceutical and academic sectors. Proven track record in technical and scientific writing, quality assurance, data analysis, and project management (PMBOK). Strong expertise in process optimization, regulatory documentation, and modeling of bioprocesses. Adept at reviewing scientific content, mentoring technical staff, and aligning work with GMP, FDA, ICH, and ISO standards.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Researcher (COMECYT Program)
Technological Institute of Higher Studies of Ecatepec
05.2023 - Current
- Experimental design and results validation
- Scientific article writing and conference participation
- Root cause analysis and process deviation resolution
- Technical staff development and laboratory resource optimization
- Achievement: Published mathematical model of enzymatic production kinetics in Biochemical Engineering Journal
Master’s Researcher – Biochemical Engineering
CONACYT
01.2020 - 12.2022
- Bioprocess development and optimization
- Modeling using Flex PDE and Polymath
- Presentations: XLIII National Meeting of AMIDIQ; publication in CIBCA 2021 eBook
Six Sigma Implementation Chemist
Primary Health Care Center (CEAPS)
01.2018 - 07.2018
- Statistical process analysis and control of critical variables
- Implementation of process improvements and staff training
- Result: 20% reduction in external quality assessment nonconformities
Quality Systems Expert
Bristol Myers Squibb
02.2014 - 07.2016
- Review and approval of manufacturing documents (protocols, validation, APRs)
- Change control, CAPAs, and audit follow-up (FDA, INVIMA, COFEPRIS, ANVISA)
- Key Role: SAP QM module key user for enterprise ERP implementation
Project Lead – SAMPLE MANAGER LIMS
01.2013 - 01.2014
- Full project life cycle (analysis, implementation, testing, release)
- Staff training and alignment with headquarters requirements
- Outcome: Timely and successful system deployment
Documentation Chemist
08.2010 - 01.2013
- Design and follow-up of stability studies
- Trend analysis, report writing, and quality investigations
- Efficiency: Reduced report review time using VSM; earned internal Yellow Belt
Finished Product and Stability Analyst
07.2007 - 08.2010
- Routine QC of finished and stability products
- Instrument calibration and qualification compliance
Education
M.Sc. - Biochemical Engineering
Technological Institute of Higher Studies of Ecatepec
01.2022
MBA - Quality and Productivity
Universidad TecMilenio
01.2019
B.Sc. - Biochemical Engineering
Technological Institute of Higher Studies of Ecatepec
01.2007
Skills
- Technical and scientific writing (English and Spanish)
- Clinical and statistical data interpretation
- Regulatory documentation (SOPs, CAPAs, protocols, reports)
- Project management (PMP certified)
- Six Sigma improvement strategies (Green Belt)
- Staff training and mentoring
Certification
- PMP – Project Management Professional
- Green Belt – SigmaPro
- ISO 9001:2015, APQP
- Familiar with ICH, FDA guidelines, and AMA Manual of Style
- Tools: SAP QM, SAMPLE MANAGER LIMS, Flex PDE, Polymath
- Software: Microsoft Office Suite, Canva, Prezi, Zoom, Teams, Google Classroom
- English: Upper Intermediate (B2)
Timeline
Researcher (COMECYT Program)
Technological Institute of Higher Studies of Ecatepec
05.2023 - Current
Master’s Researcher – Biochemical Engineering
CONACYT
01.2020 - 12.2022
Six Sigma Implementation Chemist
Primary Health Care Center (CEAPS)
01.2018 - 07.2018
Quality Systems Expert
Bristol Myers Squibb
02.2014 - 07.2016
Project Lead – SAMPLE MANAGER LIMS
01.2013 - 01.2014
Documentation Chemist
08.2010 - 01.2013
Finished Product and Stability Analyst
07.2007 - 08.2010
MBA - Quality and Productivity
Universidad TecMilenio
B.Sc. - Biochemical Engineering
Technological Institute of Higher Studies of Ecatepec
M.Sc. - Biochemical Engineering
Technological Institute of Higher Studies of Ecatepec
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