The Presentation Statements of Valuation of a | Corporation | Entity | Individual | Worker | are described in the text references listed on this site.
Yerai Oliveras Sánchez
Corporate Telephone: 1.939.456.4949; yeraioliveras@gmail.com
Address for Correspondence: 1420 Atlantic Avenue #210, Brooklyn, NY 11216
Chemist | Chemical Engineer
The Synthetic Forest
This presentation contains the information requested.
VALUATION STATEMENT
The Synthetic Forest integrates technology transfers to the function of custom emissions in the digital and physical marketplace.
DISCLOSURE OF INTELLECTUAL PROPERTY
Product Developer Quality Lead Lab Director for Pharmaceutical Herbal Biopharmaceutical Consumer Products.
21CFR, 40CFR, 7USC Department of Agriculture Business Development Engineer.
Owner of Trade name Synthetic Forest
Managerial experience in federal regulated environments on installations for validations, biopharmaceutical manufacturing, experimental research, air pollution control and heavy industrial power and mining to comply with
International Standards USC, CFR, FDA, EMA, ISO, ICH, NFPA, EPA, CDC, ASME, NIST, NESHAP, GXP.
Patent Originator and administrator of property owned entirely.
Clinical Trial coordination for IND, NDI molecular or instrumental applications in the
Audiorespiratory Autonomic System
NeuroLymphatic Circulatory System
Chronic or Acute Oncologic System
Chemical Engineer with extensive chemistry and engineering experience allowing skills to contribute across the board on a chemical site. Leadership skills balancing time, budget and customer satisfaction for optimal delivery. Immediate contributor in technical troubleshooting, inspections, retrofit, budget reduction, field investigations as well as technical consulting operations. Passport Ready, Chemist License 5119.
EDUCATION
Juris Doctor Program California Southern University 2019One Trimester ( No graduation )
PhD Neuroscience Program Vanderbilt University 2004-2005
One Year ( No graduation )
BS Chemical Engineering University of Puerto Rico at Mayaguez 2007-2010
GPA 3.25
2010 Perry’s Chemical Engineer
BS Chemistry University of Puerto Rico at Mayaguez 1999-2004
GPA 3.40
Magna Cum Laude
2000-2002 Athletic Scholarship
2003 and 2004 Distinguished Student of Arts and Science
2004 MARC Honors Fellow
LICENSE
License Colegio de Químicos de Puerto Rico 2005 Licensed Chemist 5119
PROFESSIONAL ENGINEERING SERVICES
● Grant Wrtiting, Review, Administration.
● Consultant on the basis of Chemical, Engineering, Materials and Physical phenomena to improve Process and Product Performance.
● Quality Engineering to Standardize business practices for Local and National Compliance.
● Validation of Installed Units for Process Standardization, Process Control and Optimization.
● Intellectual Property Management for the Expansion of Current Product Portfolio.
● FDA, EMA, ISO, CFR, GMP, NFPA, EPA, CDC, ASME, NIST, ICH and other regulatory bodies to meet,
● operational, quality, safety, purity, technological and installation requirements.
● Compliance Analyst
● Industrial Project Management in Chemicals, Construction, Banking, Financier, Home Ownership.
● Liquid, Solid, Gas, Process Loss Analysis.
● Test Method development and Traceability of Structural and Functional Requirements.
● Advisor to Laboratories on Process improvement Investigations against and along In-Process Optimization Strategies to deliver On-Time product to market.
● Facilitate the Introduction of New Products from User Specifications to R&D (FAT) to SAT/IQ/OQ, to Market.
● Custom Formulations to meet User Requirements Specifications.
● Identify Engineering Scope and Priority Requirements to develop an agreed Engineering strategy that meets Financial resource requirements.
● Coordinate Laboratory Analysis for Reliability, Quality and Performance.
● Identify Roadblocks or Workflow dynamic lags in Company Performance.
● Consult on Companies’ New Product Portfolio aiding R&D in establishing New Drug Targets.
● Line Recalibration, Cpk, Ppk, Center lining to Target utilizing Lean Manufacturing Tools.
● Statistical Process Modeling
● Ability to Meet CQA Black Belt Certifications on Project Tasks.
● Process Capability Analysis of Critical Process Parameters Attributes for Pharmaceutical processes.
● Introductory JMP, Minitab and Python experience for industrial data modeling.
● Programmer for Chemical Process Yield to Efficiency 100/100 99/100 100/99
● Batch Record Editing and Data Analysis for Stepwise/Global Processes.
● Controlled Drug Process Statistics and Laboratory Analysis.
● Established New Drug Product Monitoring Strategies for Continuous Process Monitoring.
● Technical Oversight and Troubleshooting of all Solid Dosage Manufacturing Steps.
● Consulting on Compliance matters related to Federal Enforcement of Drug Manufacturing.
● Solids Sampling, Sieve Tray Analysis, Particle Size Distribution, Stack Testing and NDT Testing.
● Troubleshooting of Solid Dosage Tablet manufacturing steps.
● Material Qualification for Critical Product Contact.
● Process Optimization Strategies to deliver On-Time product to market.
● Cost Analysis, Projection and Depreciation Analysis for Startup Businesses in Present to Future Models.
● Determine engineering design functions on the basis of technical expertise workload and project size/complexity, while monitoring individual's performance against personal targets.
● Basic understanding of Chemical Kinetics for Pharmacological Approaches in Drug Research.
● Manage, monitor and report on the status of the portfolio of projects to ensure that all physical and financial resource requirements are identified, sourced and maintained to achieve successful and timely project completion.
● Customer Service via telephone or conference or in person.
PROFESSIONAL EXPERIENCE
ISUN VISIONS - Ridgway CO Lab Manager APR2019 - DEC2019
Direct Hire Employee
● Trademarks Isun, OM Pur, Annmarie
● FDA Inspection with Zero Observations.
● Formula Manufacturing and Quality Management for High End, Best-In-Class products.
● Quality Control of all incoming ingredients and outgoing finished products.
● Inventory Control for over 400 ingredients and parts.
● Supervision of 5 employees.
● Scheduling of Manufacturing Schedule for On-Time product manufacturing.
● www.isunskincare.com
GREEN HEMP FARMS Delta CO Process Manager MAR2018 - DEC2018
Direct Hire, Employee
● Supercritical CO2 Extraction Lead
● Quality Control Lab Design
● Extraction Process Logistics, Troubleshooting and Consulting.
● Front Office Manager
● Supervision of 4 Employees
● www.greenhempfarms.com
GREENTECH LABS Startup Manufacturing Development; NOV2015 - DEC 2019
Startup Chemist Engineer Formulator
● Consulting for Business Development
● Cost Savings; Formula Development; Process Corrections.
● Formulation Development
● Implementation of cGMPs into Herbal Product Applications
● Transdermal Product Development
● Introduction to Patent Submission
PRECISION BIOLOGICS Marietta GA Chief Engineer SEP2016 - NOV2017
Direct Hire, Contract
● Managed Budget of 2 Million for acquisitions, and New Product Development.
● Clinical Trial Coordinator for NDI, IND of new materials.
● Developed COOP Program with the University of Puerto Rico at Mayaguez.
● Validation of Units for Extraction, Processing and Derivatization of Raw Chemicals.
● Formulation of Products for Consumption from Natural Raw Materials.
● Transitioning Consumer Product Manufacturing Site to Clinical GMP Grade.
● Expansion of Market Reach to New States.
● Trained and Mentored Employees on Equipment Execution, Cleaning, and Chemistry.
● Directed Material Acquisitions and Resources for Manufacturing.
● Organic, Analytical Chemistry for Research and Development.
● Purchasing of Materials for Scaled Up Manufacturing.
● Edition of Protocols for Formulation of Consumables.
● Research and Development for Liposomal Preparations.
PFIZER Barceloneta PR Validation Specialist NOV2015 - JAN2016
Contractor: Avila Consulting Group
● Full Validation Life Cycle Support for New Product Formulation: Loading, Mixing, Granulation, Compression, Wet Coating, Laser Drilling, Cellulosic Coating, Printing.
● Characterized the entire XL Technology Manufacturing Line for Federal regulatory compliance.
● Operational Qualification of Spray Coater for On-Alarm limits.
● Checked Structural and Functional requirements for Qualification.
● Material Evaluation and Qualification for Surface Contact Manufacturing.
● Support on Internal Audit of Product loss Accountability during Solid Dosage Manufacturing.
● Batch Record Data Acquisition and Analysis for Controlled Drugs.
● Material Loss Accountability oversight for the entire Solid Dosage Process.
● Troubleshooting of Laser Drilling Machine and Printing Machine during Validation OOS.
ZIMMER-BIOMET Ponce PR Cleaning Validation Specialist MAY 2015 - AUG2015
Contractor: Conde Indu Services
● IQ/OQ, and CSV, of Ultrasonic Cleaning System.
● Optimized Cleaning Sequence timing, Soap Concentration and Drying Temperatures.
● Designed the First Study of CIP-100 Intermediate Cleaning Effects prior to Nitric Acid Passivation.
● Wrote Operational Procedure, Calibrations Procedure, and Replacement Inventory.
● This Cleaning Study was replicated in 4 ELMA and Blackstone Ultrasonic Cleaning Systems.
● Coordinated Sampling with External suppliers for custody, analysis and reporting.
● Study was quoted under HPLC, TOC, Titration, and IR Methods.
● Soiling Agents were identified and Submitted for Analysis.
● Led Calibrations Coordination to meet IQ qualification.
● Passivation Acceptability Criteria was used as a benchmark.
● Supported External contractors for PLC logistics and Infrared sensor adjustments.
● Troubleshooting of Heat Exchanger PID parameters with external vendors.
LILLY Carolina PR Pharmaceutical Engineer SEP 2014 - JAN2015
Contractor: Pharma Serv
● IQ Validation of Experimental Fermentation Pilot Plant for E Coli for Biopharmaceuticals.
● Transfer Package documentation for Fermentors, Seeders, and Ammonia Dispensing Room.
● Checked PIDs for identification, configuration and Installation.
● Identified URS for edition and execution of Installation Commissioning Protocols without supervision.
● Supervised data entry personnel completing Transfer Package.
THE PRINCETON REVIEW Hato Rey PR Organic Chemistry Trainer JUN 2014 - JUL 2014
Contractor
● San Juan, Puerto Rico: Taught Organic Chemistry for undergraduate students to take the 2015 MCAT.
● Mentored and Motivated Students from diverse backgrounds towards achieving subject matter expertise.
● Organized Courses under Princeton Review guidelines for teaching and presentation of material.
PROCTER AND GAMBLE Cayey PR MPD Engineer AUG 2012 – APR 2014
Direct Hire, Employee
● Materials-Process-Delivery Site Engineering Manager.
● Department CAPA-EV Owner: Reduced Total CAPA count by 30%.
● Site Process CAPA Owner: Master Recipe Corrections, Process Corrections, Supplier Process.
● Verification, Scale Up Review, Cleaning Batch Process Modeling.
● Packaging Delivery Tracking.
● International Manufacturing Cross Site Troubleshooting.
● Led Transition from Cosmetic (FD&C Act) to Pharmaceutical Regulatory Compliance.
● Owner of several Product Manufacturing Processes: 4, 6, 10 Ton Tanks.
● Industrial Emulsification Subject Matter Expert.
MEDTRONIC Juncos PR Quality Engineer MAR 2012 – MAY 2012
Contractor: Lean Enterprise Consulting
● Process Auditing and Correction of Rapid Assembly Machine.
● FMEA of Syringe Assembly Machine.
● Consulting for Process Streamlining and Corrections.
BRISTOL MYERS SQUIBB Manati PR Quality Engineer MAY 2011 – AUG 2011
Contractor: Esteves Consulting Services
● Calibrations Department Investigations Lead for ISO5 facility in Biopolymer Drugs.
● Carried independently investigations for Lyophilization, Particle Counter, and Illumination on ISO5/8 Biopolymer Manufacturing Line.
ENVIRONMENTAL POLLUTION SOLUTIONS COOP Engineer AUG 2009 – JAN 2012 COOP
● Awarded EPSWWS COOP Scholarship.
● Established the First office of Electrostatic Precipitation Consulting in Puerto Rico.
● Complete On-line and Off-line inspection and analysis of equipment.
● Coordination of supervision of all recommended repair / retrofit work.
● Inspections and Consulting Commission for ESP-Boiler stoppage.
● Rapper and TR Set Inspection.
● Hull and Diffuser Plate Inspection.
● Characterization of Resting Layer using Furnace Methods.
● Dry Side ESP Unit Start-up in Colombia.
● Authored the Stack Testing Training Seminar and Lead and Selenium Reduction Program.
● Edited ESP Field Manual and Drafted a translation of a Spanish ESP book.
● Trained New COOP students on 40CFR methods for Stack Testing and ESP design.
● Fire Protection Training under NFPA and Marine Chemist Qualifying Board Training.
● Analytical Laboratory Design applicable to ESP and Boiler inspections.
PFIZER Vega Baja PR Quality Control Chemist; NOV 2005 - OCT 2006
Contractor: Adecco
● HPLC, IR, UV and GC analysis of Finished Drug Products.
● Degradations, Dissolutions, Identity, Purity testing.
● Managed Wet Chemistry Preparations of department.
SKILLS
● COMPUTATIONAL: HTML5, CSS; Introductory: Javascript, Python
● CHEMICAL: GC-MS, HPLC-MS, Chromatography, Extraction, Catalysis, Synthesis, Detection, UV VIS-IR, Calorimetric, Gravimetric, Analytical Methods.
● BIOCHEMICAL: Fermentation PCR, Assays, IR, UV Electrophoresis, BLAST, Cell Culture,
Protein Isolation-Purification-Function.
● PROCESS: Centerlining, Process Startup, Process Correction, Redlining, Walkthrough, Heat Transfer, Process Modeling.
● FORMULATION: Creams, Gels, Lotions, Toners, Transdermals, Capsules, Juices, Therapeutics, Toners, Masks, Aromatherapy, Facial Oils.
● Consumer Products.
● PHARMACEUTICAL: CFR, ISO, US Pharmacopeia, Orange Book, JP, OECD.
● VALIDATION: URS, FAT, IQ/Cleaning/OQ/PQ, Commissioning.
● QUALITY: Commissioning, Technology Transfer.
● STATISTICS: Python, Excel, JMP.
● CONSTRUCTION: Training on NFPA Fire and Electrical Codes.