Miguel A. Mercado Santiago
QC Senior Associate
Caguas
Summary
Detailed Oriented and analytical scientist capable of senior level support in any laboratory setting. Proven track record of working independently and making timely decisions that have a positive impact on projects. Adept at developing and managing detailed testing and documentation. Highly focused and dedicated to ensuring the integrity of work. Fluent in Spanish and English.
Overview
8
8
years of professional experience
Work History
QC Senior Associate
CytoImmune Therapeutics
10.2021 - Current
- As part of a multi-disciplinary team developing Analytical Methods, Standard Operation Procedure(SOP), Protocols and data analysis I support the advancement and start up of Cytoimmune Therapeutics pipeline.
- Contribute to the qualification, validation of analytical methods, product characterization, and quality attribute assessment of cellular therapy products.
- Execution of laboratory experiments to support the development and validation of analytical methods for cell therapy programs.
- Essential team member of the Environmental Monitoring Program for the manufacturing area of CytoImmune Therapeutics. Created and implement GMP EM Program.
- Layout creator for several laboratory and Manufacturing rooms for CytoImmune Therapetucis Toa Baja, Puerto Rico and Duarte, California.
- Analyze experimental data and ensure timely documentation and record keeping.
- Responsible for documentation of experimental data, generation of high-quality written study protocols, technical reports, and oral presentations.
- Ensures a productive and development rich environment, provides training/ mentoring for junior staff, Interns and leverages expertise in laboratory technology.
- Author, review and approve technical documents (protocols, reports, test methods,SOP, etc.) or content ensuring high technical standards and compliance with applicable regulatory guidelines to support analytical methods
- Participate in the validation and transfer strategy of analytical methods to support cell therapy product release.
- Implementation of new technologies by creating and implementing several data gathering platforms using Smartsheet and Microsoft Power BI in other departments, Engineering and IT.
- Participate with other departments groups to evaluate and implement new technologies related to analytical methods for cell therapy products
- Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
- Identify, builds, and maintains relationships with vendors.
- Carried out day-day-day duties accurately and efficiently.
Associate Quality Control
Amgen Manufacturing Limited
01.2018 - 10.2021
- Held responsibility for the analytical testing, characterization, sample, and data management while working with little supervision
- Ensure quality and integrity in all tests, complied with safety guidelines, cGMPs, and other regulatory requirements
- Managed specialized equipment and participated in the document revision process
- Identified roadblocks to task completion and collaborated with line management for a timely resolution
- Prioritized tasks and worked within deadlines
- Performed laboratory procedures and provided concise laboratory documentation
- Applied broad-based research and analytical capabilities to factual information
- Experience in cost reduction projects improving productivity and efficiency
- Cross training experience in other laboratories: Microbiology, Environmental Monitoring and Stability Laboratory
VWR Catalyst Laboratory Glassware Technician
The Genomics Institute of the Novartis Research Foundation
10.2017 - 02.2018
- Maintained the proper processing of lab glassware to ensure safety and availability of equipment
- Reformed and maintained Standard Operating Procedures
- Managed inventory of glassware and glass-washing supplies.
- Carried out day-day-day duties accurately and efficiently.
Cell Culture Laboratory Technician
Lilly Del Caribe
01.2015 - 12.2017
- Utilized technical abilities in generation of primary data to support the advancement process, optimization, and daily manufacturing
- Contributed to daily manufacturing activities within the Fermentation Culture Lab
- Developed and provided the appropriate test methods for the analysis of in-process and bulk drug substance experiments designed to increase product knowledge
- Designed and executed lab scale experiments to advance process knowledge with a focus on process optimization
- Analyzed fermentation process samples for sterility and bacterial contamination.
Education
Bachelor of Science - Microbiology
University of Puerto Rico
Arecibo, Puerto Rico06.2013
Skills
- Smartsheet-Modern Project & Work Management Platform
- Microsoft Power BI-Data Visualization
- SketchUp PRO - Rendering Software
- Delta V Systems
- CIMS-Consumable Inventory Management Software
- Citrix LMS & LMES-Laboratory Information Management System
- IBM Maximo
- BRIO Intelligence Platform
- GDMS BlueCielo
- Lighthouse LMS Xchange Program
- Microbial Air Sampler, Viable - ActiveCount100H & Non-Viable - ApexZ3 & ApexZ3
- Project Management
- Clean Rooms
- Climet-Model Microbial Sampler
- Laboratory Aseptic & Safety Techniques
- Decision Making
- cGMPs
- Laboratory Manufacturing
- Upstream Biotechnology
- Organizational Skills
- Problem Solving
- Sample & Data Management
Languages
Spanish
Native language
English
Proficient
C2
Timeline
QC Senior Associate
CytoImmune Therapeutics
10.2021 - Current
Associate Quality Control
Amgen Manufacturing Limited
01.2018 - 10.2021
VWR Catalyst Laboratory Glassware Technician
The Genomics Institute of the Novartis Research Foundation
10.2017 - 02.2018
Cell Culture Laboratory Technician
Lilly Del Caribe
01.2015 - 12.2017
Bachelor of Science - Microbiology
University of Puerto Rico
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