Profile Details

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USD 150 /hr

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Hire Dr. Lorena P.

Puerto Rico

USD 150 /hr

Bioengineering Technical Leader | Innovation & Process Excellence Expert

Profile Summary

Lorena is Bioengineering Technical Leader | Innovation & Process Excellence Expert Accomplished PhD Chemical Engineer with over 14 years of experience delivering commercial bioengineering solutions across the Medical Device, Pharma, and Printed Circuit Board industries. A certified ASQ Six Sigma Black Belt and Professional Engineer, Dr. Padró Cortés specializes in bridging the gap between complex scientific research and scalable, market-ready products. Core Competencies Bioengineering & Scientist Leadership: Expert in material characterization, molecularly imprinted hydrogels, and biosensor applications. New Product Introduction (NPI): Proven track record leading the launch of combinational products, including pre-filled syringes, auto-injectors, and insulin delivery systems. Process Excellence: Mastery of Lean Six Sigma tools, Design of Experiments (DOE), and Flawless Project Execution (FPX) to drive multimillion-dollar cost reductions and productivity increases. Quality & Regulatory Compliance: Extensive experience with FDA, ISO 13485, and ISO 9001 standards, including cleaning validation and risk management (FMEA). Digital Transformation: Skilled in developing Learning Management Systems (LMS) and mobile health technology for remote patient monitoring.

Subject Matter Expertise

• ☆ Data Analysis
• ☆ Predictive Modeling & Analytics
• ☆ Data Processing
• ☆ Data Exploration
• ☆ Data Visualization
• ☆ Big Data Analytics
• ☆ Data Collection
• ☆ Data Management
• ☆ Pattern Recognition
• ☆ Business Analytics
• ☆ Engineering Design
• ☆ Information & Knowledge Management
• ☆ Drug Discovery
• ☆ Hit-to-Lead & Lead Optimization
• ☆ Drug Development
• ☆ Drug Substance Characterization
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Manufacturing
• ☆ Pharmaceutical Process Development
• ☆ Bioprocess Development
• ☆ Small Molecule Manufacturing
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Device Prototyping
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Biomarker Analysis
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Product Evaluation
• ☆ Material Sourcing
• ☆ Reverse Engineering
• ☆ Supply Chain & Logistics
• ☆ Stability Testing
• ☆ Shelf-Life Testing
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Validation
• ☆ Product Compliance
• ☆ Concept Development
• ☆ Product Launch Support
• ☆ Packaging Design
• ☆ Software Development
• ☆ Software QA & Testing
• ☆ Mobile Application Development
• ☆ Desktop Application Development
• ☆ Web Application Development
• ☆ Cloud Application Development
• ☆ DevOps
• ☆ Hypothesis
• ☆ Research Methodology
• ☆ Survey Design & Methodology
• ☆ Feasibility Studies
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Presentation Design
• ☆ Instructional Webinars
• ☆ Skills Training
• ☆ Regulatory Writing
• ☆ CMC Documentation
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Technical & Scientific Writing
• ☆ Instructional Materials
• ☆ Experimental Protocols
• ☆ SOP & Protocol Writing
• ☆ Spec Sheets
• ☆ Literature Review
• ☆ Systematic Literature Review
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing
• ☆ Creative Writing
• ☆ Grant Writing
• ☆ Formulation
• ☆ Pharmaceutical Formulation
• ☆ Personal Finance & Budgeting
• ☆ Fundraising
• ☆ Business Finance
• ☆ Business Operations
• ☆ Business Strategy
• ☆ ERP/CRM/SCM Implementation
• ☆ Business Statistics
• ☆ Business Education
• ☆ Small Business
• ☆ Data-Driven Decision Making
• ☆ Customer Service
• ☆ Entrepreneurship
• ☆ Lead Generation
• ☆ Innovation Management
• ☆ Project Management
• ☆ Risk Management
• ☆ Six Sigma
• ☆ Management Consulting

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing

Research Feasibility Study, Gap Analysis

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting

Data & AI Statistical Analysis, Data Visualization

Product Development Formulation, Recipe Development, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing

Work Experience

Scientific and Engineering Director

InnovaCreate

October 2025 - Present

Technical Consultant powered by InnovaCreate

CDBG DR-MIT Government Program

December 2020 - Present

Sr. Project Manager with InnovaCreate Contractor at J&J Janssen Gurabo, Puerto Rico

Johnson and Johnson

June 2025 - September 2025

NPI Sr. Principal Engineer

InnovaCreate

April 2017 - September 2025

Sr. Project Manager with InnovaCreate Contractor at AMGEN Juncos, Puerto Rico

Amgen

March 2022 - November 2024

Project Quality Engineer

Sartorius

September 2020 - March 2022

NPI & Life Cycle Staff Scientist

Johnson and Johnson

July 2014 - April 2017

Education

PhD Chemical Engineering

University of Puerto Rico

January 2000 - June 2009

Certifications

• Data Landscape of GenAI for Project Managers

  Project Management Institute

  https://www.credly.com/badges/0ef9b576-757a-449d-8c1f-5234b8d6cb60/linked_in_profile

  May 2025 - Present

• Practical Application of Gen AI for Project Managers

  Project Management Institute

  https://www.credly.com/badges/591eff52-7d42-4902-9c3b-a0e5b56aa6ef/linked_in_profile

  April 2025 - Present

• Innovation and Entrepreneurship Certification

  Stanford University

  https://online.stanford.edu/innovation-and-entrepreneurship-program

  April 2021 - Present

• ASQ Six Sigma Black Belt

  American Society for Quality

  https://credentials.asq.org/253df4e3-fecc-47c6-8165-9cdcecb965d1#acc.FtH035ED

  January 2026 - December 2026