Erwin Calderón-Seda

Development Scientist Contractor and Consultant

Synthetic Organic-Analytical; Pharmaceutical-Medical Devices Operations; Cannabis Science and Technology

Myrtle Beach SC, 787-***-****

acz7sn@r.postjobfree.com

Overview:

An enthusiastic hands-on senior level scientist with experience in facilities engineering designing in pharmaceutical, medical devices, environmental and cannabinoids operations. Group management skills as direct supervisor, senior management in charge of managers, supervisors and analysts. Subject matter expert in all classes of laboratory non-conformance investigations like out of specifications (oos), out of trending (oot), and GMP auditing . Subject matter expert in manufacturing incidents control including generating FDA 483 reports, especially those requiring complex non-routine analytical investigations like unknown substances structural elucidation and source identification. Fluent oral and written communication in English and Spanish, intermediate reading and conversational Portuguese.

Education

ME (Studies) Material Engineering; University of Puerto Rico, Mayaguez, PR (2017 – 2018)

MS Organic-Polymer Chemistry; University of Puerto Rico, Mayagüez PR (1988)

BS Chemistry; Sacred Heart University, San Juan PR (1981)

Publications and Presentations

MS Thesis: Synthesis of Alternating Copolymers Containing Nucleic Acid Bases Pendant Groups as Viral Reverse Transcriptase Inhibitors

Provisional patent application: Methods For Preparing N-Alkenylcarboxamide Monomers, Polymers including Such Monomer Subunits, and related Compositions, Biomedical Devices, and Uses Pat. App. 60/939/786

Regulatory Investidation; Lean Six Sigma Green Belt Certified, CAPA analysis, Non-Conformance, and out of trending investigations, Analytical Method SOP and data evaluation, FDA 483 responses.

Engineering Skills; Translate an attractive business curiosity into viable advanced manufacturing concept and from there into a viable engineering design of a Ton per day Hemp processing throughput.

Work Experience:

December 2019 – Present; Director Manufacturing Operations, Carolina Botanicals, Myrtle Beach SC

Hemp cryogenic plant design that converted a turnkey CO2 business proposition into an ethanol exaction design with six times the original throughput at just a 15% capital increase based on cryogenic ethanol extraction manufacturing capable of delivering 8.3kg of either full spectrum or high purity oil every 65 minutes from 50kg (110lbs) of Hemp material or 1050kg (2315lbs) per day (3 shifts)

Sep 2018 – December 2019; Production Manager, BAS Research, Berkeley, CA

Managed all manufacturing activities of a supercritical CO2 Cannabis extraction operation with throughput between 3.0 to 5.0kg of distilled 85%THC and CBD oils, Achieved cannabis concentrates throughput up to 5kg/day with of 95% lots over 85% potency. Lead process improvements to consistently achieve low water content in plant material before CO2 extraction while doubling the low molecular weight Terpene recovery and purification using Pope Spinning band stills. Qualify Rotachrom Centrifugal Partition Chromatography for THC removal from CBD matrices.

Aug 2017 – May 2018; Student-Research Assistant Material Science & Engineering Graduate Program UPRM, Mayaguez, PR

Courses approved: Advanced Materials, Material Chemistry, Surface Analytical Chemistry, Nano Medicine, Polymer Engineering and Graduate Seminar, ICP-MS for of Adsorption analysis of Cu Ions on Scrap Tire Material, taught Organic and Biochemistry Laboratories

Sept 2014 – Aug 2017; Scientist; López Consulting LLC Gurabo, PR

Developing of an indanthrene Blue Tint colloidal nano suspension in Hydroxyethyl Methacrylate Monomer for use as visibility tint in contact lenses and color to add to other “plastic” medical devices like surgical implants. Development of high potency hydrating serums, and hypoallergenic and hydrating facial products by proprietary 2-Hydroxyethyl Methacrylate-Methacryloyloxyethyl Phosphorylcholine Copolymers. Pharma facilities contracts in method development for surface cleaning validation, LCMS method development for E and D3 vitamins manufacturing and GC-MS of impurities in intraocular lenses.

Sept 2006 – Sept 2014; Principal Scientist Cooper Vision Southampton UK and Juana Diaz, PR

Engineer Project Manager UK; designed formulation and analytical laboratories, Principal Scientist UK; patented new synthetic route for vinylamides, Developed methods for tint suspension instability and color variability. Principal Scientist Juana Diaz, PR; developed and validated HPLC methods for all Methacrylate Based Contact Lenses leachable testing. Elucidate contaminants found in methacrylate leachable. measured tint suspension stability, applied particle size distribution dynamic and static laser diffraction scattering and rheology. Engineer Project Manager PR; designed and managed the alcohol reuse project with savings of MM/year, process formulation instability, increased formulation shelf life from one to 9 days eliminating daily formulation and monomer waste while eliminating cosmetic defects. Developed, managed and validated formulation degassing project increasing all methacrylate lens yield by 10% without pre-polymerization, developed and managed pre-curing stint suspension process step that increased the formulation shelf life from 1 to 9 days and eliminated cosmetic problem,

July 2005 – Sept 2006; Environmental Laboratory Manager BVI Laboratories; Tortola BVI

Performed capability assessment based on available analytical equipment and operational condition presented findings to BVI board of director, developed laboratory operational gap analysis and calculated capital funds needed to reach full operational capacity, identify testing capabilities that could lead to an operational break-even point from current state.

August 2003 – July 2005; Validation Project Manager, Pall Biomedical Fajardo, PR

Created custom protocols for the leachables validation of pharmaceutical grade filters and designed test for individual customer process configuration, coordinated with the chemistry laboratory the specific parameters for the validation experiments based on the client-approved protocol, Produced filter validation reports for each client.

Jan 1993 – August 2003; Organic Chemistry Faculty, UPR Aguadilla,

Taught Organic, General, Pharmaceutical and Environmental Chemistry Courses and Laboratories, Coordinated departmental General Chemistry courses.

Dec 1990 – Jan 1993; In Process-Development Laboratory Manager BMS Barceloneta, PR

Designed, staffed, trained and managed the analytical method development, organic synthesis and in-process laboratories. Provided technical support from pilot plant to validation and full-scale manufacturing of six new Active Pharmaceutical Ingredients (Buspirone, Sotalol, Fosinopril, Monopril, DDI, Nefazodone) developed and Validated Cleaning Validation Protocol for Multi-Product API Chemical Plant, Developed LC and GC methods for reaction impurity monitoring, and spent solvents characterization.

June 1988 – Dec. 1990; QC Chemistry Laboratory Supervisor, Du Pont Aguadilla, PR

Supervised QC laboratory including raw materials, in-process, and finished products operations, designed new laboratory facilities for the testing of new products, hired, trained and qualified 10 analytical chemists designed new laboratory facility, transferred and validated all analytical methods for DuPont cough syrups manufacturing Long Island facility to Aguadilla PR formulation plant,

Job related analytical trainings:

(2016) Agilent; Humacao PR, Liquid Chromatography – Mass Spectrometry including Atmospheric Pressure Ionization and Electron-Spray Modes

(2013) PSS Instruments; Port Richey FL Particles Characterization including, Single particle Obscuration, Dynamic Laser Scattering Z potential measurements

(2011) TA Instruments; Wilmington DE, Pulse Rheology and Calorimetric Analysis (DSC, MDSC and TGA)

(2007) Malvern Instruments; Southampton, (UK) Static and Dynamic Laser Scattering, Rheology (Malvern Instruments), Surface Mapping FTIR and NIR Microscopic Analyses

(2006) University of Oklahoma Stark Energy Center; Oklahoma City (USA), Forensic Analysis of Hydrocarbon Mixtures by stable isotope mass spectrometry/GC forensic identification of hydrocarbon spills in sea and fresh water streams.

(2005) Marine Center Laboratories-Agilent; Tortola BVI, Elemental Analysis by ICP- MS

(2001) BMS; Barceloneta (PR), Chromatographic Method Development, Statistical Data Analysis, Analytical Method Validation, CIP process and method development including submission to FDA for approval

(2002) Nicolet Instruments; Madison Wisconsin, FTIR Spectroscopy

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