Clemente Hernandez
Geneva
Summary
Results-driven Pharmaceutical Engineer and Project Manager with over 10 years of experience in process optimization, pharmaceutical development, and technology transfer. Demonstrated success in reducing costs, improving operational efficiency, and ensuring compliance with international regulatory standards. Skilled in leading cross-functional teams, implementing Lean Six Sigma methodologies, and effectively managing global projects within the pharmaceutical and biotech industries.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Senior Process Engineer | Project Manager
FERRING
12.2023 - Current
- Lead engineering and industrial process improvement projects for pharmaceutical solid forms
- Optimize and validate industrial processes, achieving annual cost savings of €1M
- Author and review key documentation, including risk assessments, validation protocols, and reports
- Conduct cleaning optimization and validation activities
- Provide technical support for new process equipment implementation
- Drive continuous improvements using Lean Six Sigma methodologies
- Manage API suppliers, customers, and subcontractors while ensuring strong industry networks
- Support deviations, CAPAs, and procedural updates in collaboration with production teams
- Improved product quality by conducting root cause analysis on process deviations and implementing corrective actions.
- Modified production processes to reduce non-conforming material occurrences.
- Optimized processes to reduce cost and increase efficiency.
Pharmaceutical Development Project Leader
BIO ELPIDA
05.2021 - 12.2023
- Successfully led the development and regulatory submission of novel cell-based cancer therapies across all clinical phases (1-3)
- Managed projects from development through regulatory dossier submission and approval
- Spearheaded technology transfer activities from development to GMP sites
- Provided strategic updates on project scope, budget, quality, and risk management
- Led cross-functional teams, ensuring seamless collaboration between internal and external stakeholders
- Established KPI tools for project performance evaluation
- Managed project budgets, financial updates, and cost control
- Established strong relationships with clients, fostering trust and open communication throughout the entire project lifecycle.
- Conducted thorough post-project evaluations to identify areas for future improvement in both processes and performance metrics.
- Developed comprehensive project plans that outlined clear goals, timelines, and milestones for all stakeholders involved.
- Managed scope changes effectively, minimizing potential disruptions to timelines or budgets while still meeting client expectations.
- Managed team meetings and discussed project's goals and objectives.
- Reduced project risks through comprehensive risk assessments and proactive mitigation strategies.
- Consistently met deadlines by diligently tracking progress and implementing effective time management strategies.
- Successfully led multiple projects simultaneously while maintaining a focus on priorities, resource allocation, and overall strategic objectives.
- Mentored junior staff members, providing guidance on project management principles and techniques for career growth opportunities.
- Ensured compliance with industry regulations by staying informed about changes in legislation affecting the company''s operations or projects.
- Served as an escalation point for internal teams when addressing complex issues or conflicts during projects'' implementation phases.
Pharmaceutical Development & LCM Project Leader
MYLAN Global
02.2014 - 09.2017
- Managed technology transfer and life cycle projects for sterile pharmaceutical products targeting European and North American markets
- Led cross-functional teams, including external CDMOs, to drive successful project completion
- Handled regulatory risk, CAPA management, and change control processes
- Coordinated manufacturing and control testing of engineering and validation batches
- Developed and implemented a standardized Technology Transfer SOP based on QbD principles
- Planned out and executed total of [Number] projects in [Year].
- Successfully led multiple projects simultaneously while maintaining a focus on priorities, resource allocation, and overall strategic objectives.
- Coordinated vendor selection processes to secure high-quality products/services at competitive prices without compromising on deadlines.
Technology Transfer Engineer
BECTON DICKINSON
11.2011 - 02.2014
- Managed around 20 technology transfer projects ensuring compliance with regulatory timelines and quality standards
- Designed and coordinated scale-up studies and process validation batches
- Provided technical support for new drug registrations in the USA
- Collaborated internationally between R&D (France) and manufacturing sites (USA)
Pharmaceutical R&D Galenist
SCHERING PLOUGH (MERCK)
09.2008 - 09.2010
- Developed new pharmaceutical formulations (solids, liquids, semi-solids) and process optimisations
- Designed and executed formulation experiments (DoE) and pilot-scale batches
- Authored cGMP documentation, including protocols and reports for regulatory submissions
- Managed equipment qualification activities in compliance with cGMP standards
Education
Master’s - Industrial Pharmacy, Formulation & Production
Université Joseph Fourier Grenoble 1
Grenoble, France01.2011
Pharmaceutical Engineering -
Instituto Politécnico Nacional
Mexico City01.2009
Skills
- MS Project
- Forecast
- Minitab
- Design Expert
- LIMS
- Trackwise
- Microsoft Office Suite
- Matlab
- Mathcad
- Autocad
- Visio
- Leadership
- Team Management
- Problem-Solving
- Analytical Thinking
- Communication
- Collaboration
- High Adaptability
- Assertiveness
Certification
- Lean Six Sigma Green Belt Certification, 2015
- Analytical Methods Validation Training, 2015
- Lyophilization Training, 2014
- Quality by Design (ICH Q8) Training, 2013
- Project Management Training, 2012
Languages
Spanish
French
English
Portuguese
German
Hobbies and Interests
- Football
- Running
- Cycling
- Swimming
- Lyric Singing
- Traveling
- Foreign Languages
Technical And Software Skills
MS Project, Forecast, Minitab, Design Expert, LIMS, Trackwise, Microsoft Office Suite (Word, Excel, PowerPoint, OneNote), Matlab, Mathcad, Autocad, Visio
Timeline
Senior Process Engineer | Project Manager
FERRING
12.2023 - Current
Pharmaceutical Development Project Leader
BIO ELPIDA
05.2021 - 12.2023
Pharmaceutical Development & LCM Project Leader
MYLAN Global
02.2014 - 09.2017
Technology Transfer Engineer
BECTON DICKINSON
11.2011 - 02.2014
Pharmaceutical R&D Galenist
SCHERING PLOUGH (MERCK)
09.2008 - 09.2010
Master’s - Industrial Pharmacy, Formulation & Production
Université Joseph Fourier Grenoble 1
Pharmaceutical Engineering -
Instituto Politécnico Nacional
Similar Profiles
Dewi Ratna Nur HawatiDewi Ratna Nur Hawati
Product Manager at PT FERRING PHARMACEUTICALS INDUSTRYProduct Manager at PT FERRING PHARMACEUTICALS INDUSTRY
Caitlin HrubyCaitlin Hruby
Human Resources Intern at Ferring PharmaceuticalsHuman Resources Intern at Ferring Pharmaceuticals
Shaik Abdul Rauf Siddiqui LnuShaik Abdul Rauf Siddiqui Lnu
HVAC Engineer(Contract) at Ferring PharmaceuticalsHVAC Engineer(Contract) at Ferring Pharmaceuticals