Raúl L. López Maldonado
Naguabo,P.R.
Summary
Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
17
17
years of professional experience
Work History
Specialist Manufacturing AML6 Downstream
Amgen
Juncos, PR
11.2025 - Current
- Own change controls for manufacturing process changes
- Drive continuous improvement initiatives
- Support Risk Assessments exercises.
- Led commercial campaign readiness, fostering collaboration and clear communication across cross-functional teams.
- Provided assistance and guidance during the creation and revision of Master Batch Records to ensure accuracy.
- Initiate, revise, and approve standard manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
- Evaluated CAPA applicability requests from other plants and sites to determine the need for corrective actions.
- Evaluated new and revised Bill of Materials to verify accuracy and compliance with manufacturing standards.
- Fostered positive working relationships with colleagues and management to promote a collaborative work environment.
- Facilitated meetings to align team goals with corporate objectives, enhancing collaboration and focus.
Biochemist I & II
Becton & Dickinson, Biosciences
Cayey, Puerto Rico
05.2016 - 10.2024
- Conjugates monoclonal antibodies from purified material using required molecules Fluorophore or dye of the molecules, monitoring conjugation process at several stages to maximize yield and quality of conjugated antibodies.
- Conjugates according finish goods specifications for concentration following dilution batch records.
- Prepares malemaide and raw materials based on production plan requirements.
- Maintains chromatography systems in order, including column packaging cleaning and equilibrations and report any breakdowns.
- Developed protocols for testing and quality assurance of bioscience products.
- Utilized advanced laboratory equipment for precise data collection and analysis.
- Trained junior staff on laboratory techniques and safety procedures.
- Documented research findings for regulatory compliance and internal review.
- Evaluated new technologies to improve laboratory efficiency and accuracy.
- Ensured proper maintenance of laboratory instruments and safety standards.
- Operated laboratory instruments such as centrifuges, microscopes, spectrometers.
- Monitored inventory levels of reagents, chemicals, and supplies used in the lab.
- Analyzed data from biochemical experiments to identify patterns and correlations.
- Evaluated proteins using chromatography, electrophoresis, and mass spectrometry methods.
- Identified and implemented strategies for increasing equipment operating efficiency.
- Determined correct processes needed to manufacture materials to proper capacity.
- Improved formulas and processes to increase efficiency.
Manufacturing Technician
Becton & Dickinson, Biosciences
Cayey, Puerto Rico
01.2014 - 12.2015
- Perform inspection, verification for calibration and maintenance of equipment.
- Prepare materials as per established procedures.
- Perform are in process testing as per request.
- Maintain related logs and manufacturing records
- Perform daily working and cleaning tasks
- Perform packaging, cleaning and equilibration of chromatography columns as requested and scheduled.
- Maintain inventory of chemicals and labs supplies
- Support set up and manufacturing activities to the tissue culture, purification and conjugation areas.
- Processes cell supernatant to remove debris and to concentrate product before purification.
- Formulate monoclonal antibody reagents using established documentation.
- Manufactures buffer and solutions as per established procedures.
- Use equipment’s such as pipettes, micro-pipettes, balance, pH and conductivity meters and UV/Visible spectrophotometers.
- Executes Filling and Packaging process by scheduling.
- Support Quality Assurance by keeping abreast of the basic requirements for compliance.
- Participates in continuous improvement activities.
- Operated manufacturing equipment for production of bioscience products.
- Collaborated with team members to streamline assembly processes effectively.
- Maintained accurate records of production data and equipment usage.
- Inspected raw materials for quality before processing and assembly stages.
- Trained new technicians on safety protocols and operational procedures.
- Maintained a clean work area by disposing of waste materials properly.
- Assisted in training other technicians on proper use of equipment and safety protocols.
- Prepared and assembled materials and set up and operated production equipment in accordance with current manufacturing practices and standard operating procedures.
- Performed preventative maintenance on manufacturing equipment and machinery.
- Monitored inventory levels and ordered parts as needed to keep machines running efficiently.
- Documented results of all tests performed and reported any discrepancies.
- Evaluated existing processes and procedures for opportunities for cost savings or efficiency gains.
- Trained new employees on proper use of machinery and safety protocols.
- Assisted in the setup and preparation of equipment for production runs.
- Observed worker performance to verify equipment operation and maintenance.
Filling and Packaging Technician Production Department
Becton & Dickinson, Biosciences
Cayey, Puerto Rico
07.2009 - 12.2013
- Execute Filling & Packaging Process by scheduling, filling, labeling and bagging vials for purified and conjugated materials.
- Equipment used in process EDOS 5222, Biohit pipettes, Analytical balance, Duplo machine, Auto bagging Machine, Zebra Printer, Stir plate and Domino Printer.
- Generate both, vial and barcode labels, by operating label printing equipment.
- Meet daily/weekly/monthly departmental production objectives efficiently with a high degree of quality.
- Independently organize individual schedules to meet department goals.
- Generate requisitions and replenish departmental packaging supplies and materials management function including storing, retrieving and standing supplies/materials as required.
- Process Packaging data in SAP system.
- Responsible in revising and create documents for the department like: Standard Operation Procedure, Manufacturing Specifications, Batch Records and Forms.
- Trained new staff on proper packaging techniques and safety protocols in the facility.
Education
Master Degree - Environmental Management
Polytechnic University of Puerto Rico
Hato Rey, PR01-2013
Bachelor Degree - Biology
Interamerican University, Fajardo Campus
Fajardo, PR01-2009
Skills
- Task prioritization
- Multitasking
- Laboratory techniques
- Microsoft Word
- Microsoft PowerPoint
- Microsoft Outlook
- SAP system
- Languages: Spanish (Native), English (Fluent)
- Communication
- Leadership
- Analytical skills
- Ability to work under pressure
- Organizational skills
- Time management
- Teamwork
- Mathematics skills
- Knowledge of cGMP
- Knowledge of FDA requirements
- Knowledge of ISO requirements
- Knowledge of OSHA requirements
- Antibody conjugation
- Chromatography techniques
- Laboratory safety protocols
- Process optimization
- Equipment maintenance
- Team collaboration
- Technical training
- Problem solving
- Effective communication
- Technical documentation
- Product inspection
- Standard operating procedures
- Lab management
- Safety management
- Change control management
References
- Mr. Juan Lugo, Quality Manager, BD Biosciences, Cayey, PR
- Ing. Pedro Modesto, Professor, Polytechnic University & Universidad del Turabo
- Dr. Christian Villalta, Environmental Engineering Academic Department Director & Professor, Polytechnic University of Puerto Rico
Professional Accomplishments
Courses in Computers Software’s: Excel, Microsoft Word and Power Point., Trainings: Train the Trainer, QDMS Contributor, OSHA General Industry 30H., Additional trainings have been taken as part of the professional development as a BD employee: GMP, FDA, ISO and OSHA requirements., Ability to speak read and write English/Spanish., Excellent skill in Software programs such as, Microsoft Word, Power Point, Outlook and SAP system., Ability to teach., Excellent communication and leadership skills., Energetic and Innovative capable of driving results while creating a positive environment., Excellent analytical skills and ability to work well under pressure and extended hours when necessary., Ability to follow established policies and procedures., Effective organizational and time management skills., Effective ability to work in a team environment., Strong mathematics skills., Knowledge of cGMP, FDA, ISO and OSHA requirements., Knowledge of SAP System., Employee of the Year, 2010, BD Caribe LTD Biosciences, Cayey, PR, Professor certified, Ana G. Mendez University System
Timeline
Specialist Manufacturing AML6 Downstream
Amgen
11.2025 - Current
Biochemist I & II
Becton & Dickinson, Biosciences
05.2016 - 10.2024
Manufacturing Technician
Becton & Dickinson, Biosciences
01.2014 - 12.2015
Filling and Packaging Technician Production Department
Becton & Dickinson, Biosciences
07.2009 - 12.2013
Master Degree - Environmental Management
Polytechnic University of Puerto Rico
Bachelor Degree - Biology
Interamerican University, Fajardo Campus