Marie R. Santiago Quiles
Guaynabo,Puerto Rico
Summary
Scientist with robust professional background in leading cutting-edge research and development projects. Possesses strong focus on team collaboration and achieving impactful results. Known for adaptability and reliability in dynamic environments, with key skills in analytical thinking and project management. Oral and written language in Spanish and English.
Overview
33
33
years of professional experience
1
1
Certification
Work History
Principal Scientist
Kenvue
06.2022 - Current
- Lead technology transfer and process validation activities for new product introductions.
- Drive manufacturing process improvements and troubleshooting of complex process issues.
- Serve as SME in solid dosage manufacturing and support regulatory inspections/interactions.
- Lead cross-functional initiatives including cleaning validation and continued process verification (CPV).
Staff Scientist
McNeil Consumer Healthcare & Specialty Pharm.
05.2015 - 06.2022
- Generated validation protocols, technology transfer documentation, and control strategies among others.
- Lead process validation and cleaning validation projects across multiple products.
- Managed change controls, investigations, and CAPA implementation.
- Supported manufacturing and laboratory investigations with technical evaluations.
Sr. Technical Services Scientist/Sr. Technical Operations Scientist
McNeil Consumer Healthcare & Specialty Pharm.
05.2009 - 05.2015
- Led Development and Process Validation activities for the introduction of new products.
- Generated development and validation documentation in support to technology transfer activities.
- Supported pharmaceutical technology initiatives and process improvements.
- Supported of manufacturing and laboratory investigations.
- Supported Cleaning Validation Projects.
Validation Scientist
McNeil Consumer Healthcare & Specialty Pharm.
05.2004 - 05.2009
- Executed cleaning validation and process validation protocols and reports.
- Developed SOPs and supported validation master plans.
Chemical Analyst
SmithKline Beecham Pharm.
10.1993 - 06.1998
Education
Master Degree - Pharmacology and Toxicology
University of Puerto Rico, Medical Sciences Campus
San Juan, Puerto Rico06-2004
Bachelor Degree - Chemistry
University of Puerto Rico, Cayey University College
Cayey, Puerto Rico06-1993
Skills
- MINITAB
- Microsoft word
- Microsoft excel
- Microsoft Project
- Power point
Certification
- Validation Training- Institute of Validation Technology.
- Conflict Management Training.
- Careful Communication Training.
- Leadership Academy- certification completed.
- Statistical Process Control (SPC).
- Flawless Project Execution (FPX)- certification completed.
- Colorcon Film Coating Seminar.
- Green Belt Certified.
Timeline
Principal Scientist
Kenvue
06.2022 - Current
Staff Scientist
McNeil Consumer Healthcare & Specialty Pharm.
05.2015 - 06.2022
Sr. Technical Services Scientist/Sr. Technical Operations Scientist
McNeil Consumer Healthcare & Specialty Pharm.
05.2009 - 05.2015
Validation Scientist
McNeil Consumer Healthcare & Specialty Pharm.
05.2004 - 05.2009
Chemical Analyst
SmithKline Beecham Pharm.
10.1993 - 06.1998
Bachelor Degree - Chemistry
University of Puerto Rico, Cayey University College
Master Degree - Pharmacology and Toxicology
University of Puerto Rico, Medical Sciences Campus