F. Brian Kwaramba, Ph.D.

adit2u@r.postjobfree.com Mansfield, TX

Profile

Dynamic Chemical Materials Scientist seeking opportunities in advanced materials, biotechnology, formulations, and process development drawing on expertise in chemistry-manufacturing-controls (CMC), quality assurance, quality control, and research/development in laboratory and manufacturing environments.

Develop new chemical technologies and advanced materials and identify industrial/consumer applications and process control systems. Astute understanding of industrial processes and large-scale production of chemical compounds. Coordinate environmental health/safety and regulatory affairs. Drive resolution of issues related to profit, strategy, chemical synthesis, and technology application. Proven leadership in solving problems within chemistry-related and interdisciplinary team settings. Spearhead new program development, initiation of institution-building enterprises, technology transfer, and global development. Bilingual in English and Shona. Scientific Expertise Areas:

Pharmaceuticals Nutraceuticals Cosmeceuticals Consumer Goods Organic Chemistry Organometallic Chemistry Catalysis Analytical Chemistry Physical-Organic Chemistry Materials Science Nanotechnology Biotechnology Robotics (Assay Automation) Core Competencies:

Industrial Project Management Methodology Development Technology Transfer Chemical Library Development Industrial Manufacturing Scaffold Libraries Method Development and Validation Separation Sciences Product Formulation Chemistry Data Collection & Analysis Industrial Processes Process Efficiency Multi-step Chemical Synthesis Green Technologies Renewables Sustainability Environmental Health and Safety Aseptic Systems Glove Box (Argon) Reagent/Catalysis Development Supra-Molecular Constructions Education

OKLAHOMA STATE UNIVERSITY Stillwater, OK

Ph.D. in Organic Chemistry and Organometallic Chemistry 2014

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Advisor: Dr. Kenneth D. Berlin

Recognition: Research Fellowship Award; Arts and Sciences Doctoral Student Excellence Award SOUTHWESTERN COLLEGE Winfield, KS

Bachelor of Applied Chemistry – magna cum laude 2009 Advisor: Dr. Terry Barnett

Recognition: Academics and Research Achievement Award; The General Board of Higher Education and Ministry Ethnic Minority Scholarship Award; Richard and Julia Wilke Bishop’s Full Scholarship Award Professional Experience

FIORELLO PHARMACEUTICALS INC. New York, NY

Director of Production Laboratory Operations and Quality Assurance Officer 2017 – 2020

Directly responsible for researching, developing, deploying, and implementing state of the art extraction and post-extraction refinement technologies, followed by manufacturing a comprehensive selection of pharmaceutical and nutraceutical products.

In-charge of all performance, planning, organization, direction, and running day-to-day operations for manufacturing CPGs, cosmeceuticals and nutraceuticals using biosynthetically derived APIs, in accordance with cGMP quality standards.

Oversaw all manufacturing processes, systems, production outputs, research & development, quality management system, pharmacovigilance systems, supply chain management, environmental health/safety, and finished goods distribution.

Led, built, and monitored the Quality Assurance and Quality Control Function (QMS) for the entire company.

Supervised multiple laboratories, namely, organic laboratory, analytical laboratory, extraction laboratory, micro-biology laboratory, compounding laboratory, packaging laboratory and destruction laboratory.

Responsible for establishing full compliance initiatives for SOPs, policies, procedures, processes, regulations, and documents.

Guided the increase of production, assets capacity and product line diversity, while minimizing costs and maintaining high quality standards.

Developed and implemented chemical manufacturing processes, streamlining processes, process efficiencies, process workflows, new standardizations, and innovative operating procedures.

Responsible for market research and selection of instrumentation, equipment choice, assigning equipment applications, raw material selection and inventory management.

In-Charge of production, new product development, product education, and local, state, and federal compliance and regulatory processes.

F. Brian Kwaramba, Ph.D. Page 2 adit2u@r.postjobfree.com Mansfield, TX Professional Experience – continued

Monitored all operations, master manufacturing records, CAPAs, deviations, cGDocP, cGxP, SOPs, HACCP, compliance, production schedules, product distribution, budgets, employee training and capital planning.

Trained staff / employees on all GxPs, ISO standards, SOPs, and OSHA implementation.

Drove process analysis, development, optimization, scale-up, validation, streamlining, and deployment.

Built internal interface systems, manufacturing human resource base, and LIMS.

Wrote and evaluated SOPs, including documentation writing in accordance with ISO standards.

Built and managed chemical safety protocols along with biological safety practices.

Responsible for crafting and implementing document control in manufacturing.

Oversaw strategic planning to broaden the company’s product portfolio.

Established accountability metrics for supervisory staff, while ensuring safety follow-ups, investigations, inspections, and regulatory compliance.

Supervised all resource allocation, asset acquisitions, coordination of facility expansion, design of building space and layout to ensure optimal operations rooted in unequivocal technical/scientific standards.

Built out, managed analysis, prioritized, budgeted, aligned, and resource allocated for new manufacturing projects.

Led technology transfer projects, global expansion, cross-functional projects, and workflow process improvements.

Created plans for implementation of new projects, equipment, programs, measurements, and execution plans, while ensuring efficient change management.

Steered all continuous improvement initiatives, product development, process development, and process optimization from ideation to full implementation.

On-Site subject matter expert in chemistry-manufacturing-controls and quality-management-systems.

Developed business strategy, capital campaigns and financial planning.

Managed review performance, directing, recruiting, counseling, empowering, training, and developing all manufacturing employees. THE RICHARD AND JULIA WILKE RESEARCH INSTITUTE Dallas, TX Director of Global Integration and Project Management 2016 – Present

Perform strategic planning to broaden and deepen the institute’s operations portfolio and advance its goals.

Manage analysis, prioritization, budgeting, alignment, and resource allocation for international and domestic projects.

Facilitate partnerships with U.S. and international universities/colleges, research institutes, organizations, and corporate collaborators for global science capacity building and needs assessment.

Lead technology transfer projects, global expansion, cross-functional projects, and workflow process improvements.

Initiated virtual learning platforms in Singapore, laboratory seeding in southern Africa, and online learning platforms in South America, Central America, Asia, and southern Africa.

ABENGOA BIOENERGY Hugoton, KS

Quality, Safety and Environmental Manager 2015 – 2016

Provided leadership on the pilot 2nd generation cellulosic ethanol production, primarily focusing on troubleshooting pilot plant malfunctions and maximizing production processes.

Furnished turnkey solutions for commercial agriculture, chemistry and scale up.

Provided mitigation strategies by establishing engineering controls and use of protective equipment.

In-charge of matters of compliance with federal, state, county, and local environmental health and safety laws, ordinances, and regulations.

Initiated quality assurance and quality control programs from ideation to full operational applications.

Subject matter expert in implementing method development, method validation, evaluating competitors’ methods, and industry regulations.

In charge of the development and integration of CMC and QMS systems.

Managed data assessment, data tracking, data traceability in LIMS system and handwritten reports.

Conducted employee training, developed quality control processes, and controlled records in all laboratories. STERLING COLLEGE Sterling, KS

Chemistry Department Chair and Professor of Applied Chemistry 2014 – 2016

Initiated and oversaw environmental health/safety, quality control, and quality assurance programs for organic chemistry, biochemistry, analytical chemistry, and inorganic chemistry laboratories.

Taught organic chemistry, biochemistry, analytical chemistry, and inorganic chemistry.

Cultivated new scientific partnerships with private industries to provide emerging undergraduate scientists with enhanced access to resources, such as laboratory equipment, training, and professional connectivity.

Develop a vigorous, privately funded research programs involving undergraduate students interested in research and development.

Introduced programs focused on antimicrobial resistance, environmental toxicity, analytical chemistry, advanced reduction-oxidation processes, pharmaceuticals, and water treatment.

Managed department budget and other financial resources.

Supported student recruitment and retention efforts for all departmental programs. F. Brian Kwaramba, Ph.D. Page 3 adit2u@r.postjobfree.com Mansfield, TX Professional Experience – continued

HENRY BELLMON RESEARCH CENTER, OKLAHOMA STATE UNIVERSITY Stillwater, OK Doctoral Researcher 2009 – 2014

Advanced the area of organic synthesis through homogenous and heterogeneous catalysis, development of methodologies for industrial applications, and introduction of new nanomaterial.

Orchestrated and developed a novel, sterically directed iridium catalysis for the hydrosilylation of alkenes in the presence of alkynes.

Constructed a scaffold library of 40+ novel, highly functionalized alkynyl-silane compounds.

Designed and programmed library of novel triptypyrazines gearing systems that incorporate photo-chemically and electrochemically switchable moieties, aimed at developing molecular devices for nanotechnology development and delivery compounds.

Formulated and examined transition metal nanoparticles on silicon matrix and diverse assortment of polymeric capping agents for macro-scale industrial hydrosilylation catalysis.

Fabricated multifunctional, high-capture capacity, solvent-free, and photoactive carbon dioxide sequestration chemical materials for low-cost carbon capture application in commercial energy production operations.

Oversaw undergraduate, junior graduate, and fellow research staff, providing mentoring in chemical technology and training in instrument operation, maintenance, and troubleshooting within contexts of comprehensive characterization of chemical compounds, substrate design, and library development.

Trained researchers in the practice of compound synthesis, hydrosilylation catalysis, CO2 sequestration, gas storage, catalyst design, chemical diagnostics, and method development, application, transfer, and validation. Graduate Instruction Associate 2009 – 2014

Taught advanced organic chemistry, organic chemistry, biochemistry, general chemistry, calculus, biology, and college algebra courses. POLLUTION PREVENTION INSTITUTE, KANSAS STATE UNIVERSITY Manhattan, KS Industrial Engineering Auditor 2008 – 2010

Audited small businesses and industries in Kansas to assess compliance with environmental health and safety laws.

Wrote grants and prepared grant applications to federal and state funding sources.

Trained state government, and on-site staff or employees on GxP, ISO standards and their implementation.

Examined various industrial processes, followed by prescribing process optimization and novel process development. THE SCHWAN FOOD COMPANY INC. Salina, KS

Industrial Process Chemist and Chemical Hygiene Officer 2008 – 2009

Executed factory audits of water, refrigeration, sanitation, and chemical systems.

Oversaw construction of chemical inventories.

Achieved reduction of water, chemical, and energy usage, representing annual cost savings of more than $2 million.

Evaluated and prescribed stability operations to ensure compliance with cGMP, cGAP, cGLP, cGDocP, cGDP, SQF, HACCP, and other related regulations.

SOUTHWESTERN COLLEGE AND THE KANSAS UNIVERSITY MEDICAL CENTER Winfield, KS Research Assistant 2008 – 2009

Synthesized potassium 2-hydroxy-2-oxoethanethioate enzyme inhibitor for assay application in tumor tissue, aimed at oncological assessment.

Evaluated effect of esterification of carboxylic acid functional groups on plant hormones relative to orchid phytochemistry. Laboratory Technician and Teaching Assistant 2006 – 2009

Guided undergraduates in conducting laboratory work in organic chemistry, general chemistry, and biochemistry.

Built, audited, and maintained chemical inventory.

Spearheaded safe chemical handling and pioneered precautionary measures in hazardous material/safety department. Skills

Manufacturing / Laboratory Processes and Equipment Spectroscopy: Fourier Transform Infrared Spectroscopy (FTIR), UV-Vis Spectroscopy, Nuclear Magnetic Resonance Spectroscopy

(NMR), Atomic Absorption Spectroscopy (AA), Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES) Chromatography: Chromatography (TLC, NPC, RPC, SEC, IEC, SFC, GPC, CCC, FPLC, GLC), High-Performance Liquid Chromatography

(HPLC), Ultra High Pressure Liquid Chromatography (UPLC), Medium-Pressure Liquid Chromatography (MPLC), Gas Chromatography (GC), Ion Chromatography (IC), Gas Chromatography-Mass Spectroscopy (GC/MS) F. Brian Kwaramba, Ph.D. Page 4 adit2u@r.postjobfree.com Mansfield, TX Skills – continued

Spectrometry: Mass Spectrometry, High Resolution Mass Spectroscopy (ESI-MS), Inductively Coupled Plasma Mass Spectrometry

(ICP-MS), Raman Spectroscopy

Electrochemical Tech: Cyclic Voltammetry (CV)

Chemical Compound

Electron Microscopy: Scan Electron Microscopy (SEM), Transmission Electron Microscopy (TEM) Calorimetry: Thermal Analysis/ Calorimetry (DSC, ITC) Compound Synthesis: Microwave Synthesis, Original Experimental Design and Execution, Organic Synthesis and Molecular Analysis, Wet Chemistry Techniques, Comprehensive Compound Analyses Techniques, Modern Analytical Techniques, Solvent and Reagent Purification

Computational Tech: Computational Organic Molecular Modeling and Design using Spartan Linux Software, Systems Application Products

(SAP) Auditing, Statistical Process Control (SPC)

Software: ChemBioDraw, ChemSketch, ACD/NMR Processor, MestreNova, SciFinder, FoldX, MacroModel, Spartan Linux Computational Modeling (molecular modeling), BioTrack, Metrc, AutoCAD, Laboratory Information Management System (LIMS), Trackwise, Minitab, REX, MS Project, MS Office Hydrosilylation: Industrially applicable hydrosilylation catalysis, optimization, screening, scale-up, and compound library preparation Diversity-Oriented

Chemical Synthesis: Development of reagents, catalysts, and methodologies that prepare relevant compound scaffolds in an economical

(atom, redox, step) manner, with diversity

QA and QC Management Auditing industrial process data, standard operating procedures, method specification documents, establishing process control systems and improving process efficiency Nano-catalysis: Metal nano-particle catalyst design, construction, and high throughput reaction optimization; with emphasis on automated reactor design applications in conjunction with increasing reactive capacity, product selectivity, recyclability, and method development

Reactor Design: Industrial reactor design employing diverse catalysis materials and methods, including bio-catalysis Organic Compound

Synthesis: Multi-step organic synthesis and integrated comprehensive compound characterization Formulation: Multi-product line bulk formulation synthesis of libraries of pharmaceutical products, nutraceutical products, cosmetic products and chemical consumer goods, followed by their full characterization and market qualification Validation: Developing validation documents, method monographs, procedures for diagnostic method validations, and method transfers

Specialty Chemicals: Operating and handling air and moisture sensitive chemical compounds, in addition to hazardous materials Green Chemistry: Develop technology, using feedstock chemical substrates, such as CO and CO2 Computational

Chemistry: Molecular design of supra-molecular constructions in addition to their compound device applications Compliance: Enforce compliance with cGMP, cGAP, cGLP, cGDocP, cGDP, cGAsepticP, cGStorageP, CMC, SQF, HACCP, and related regulations

Extraction Technology: Botanical extraction of natural chemical compounds utilizing Ethanol Extraction Systems, CO2 Extraction Systems, Ice Water Extraction Systems, Hydrocarbon Extraction Systems Fractional Distillation

Technology: Spinning Band Fractional Distillation Systems, Wiped Film Distillation Systems, Short Path Distillation Systems Product Packaging

Automation: Robotic Automatic and Semi-Automatic Filling Systems for the following product forms: capsules, tablets, soft gels, liquid tinctures, topicals, beverages, chocolates, sprays, chewables, lozenges, frozen foods, and bulk feedstocks. F. Brian Kwaramba, Ph.D. Page 5 adit2u@r.postjobfree.com Mansfield, TX Honors and Awards

GOLDEN KEY INTERNATIONAL HONOR SOCIETY 2010 – Present ADVANCING SCIENCE GRANT AWARD 2015 – 2016

Affiliation

CHARTER QUALITY INSTITUTE (CQI) 2015 – Present

INSTITUTE OF VALIDATION TECHNOLOGY (IVT) 2015 – Present INTERNATIONAL QUALITY & PRODUCTIVITY CENTER (IQPC) 2014 – Present AMERICAN ASSOCIATION OF PHARMACEUTICAL SCIENTISTS (AAPS) 2011 – Present ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS (ACRP) 2010 – Present AMERICAN SOCIETY FOR TESTING AND MATERIALS (ASTM) INTERNATIONAL 2009 – Present NATIONAL ASSOCIATION OF SCIENTIFIC MATERIALS MANAGERS (NAOSMM) 2009 – Present AMERICAN SOCIETY FOR QUALITY (ASQ) 2009 – Present

QUALITY ASSURANCE ASSOCIATION (QAA) 2008 – Present SOCIETY OF QUALITY ASSURANCE (SQA) 2008 – Present

REGULATORY AFFAIRS PROFESSIONALS SOCIETY (RAPS) 2007 – Present AMERICAN CHEMICAL SOCIETY (ACS) 2006 – Present

Volunteer Experience

Volunteer – MY BROTHER’S KEEPER, Washington, DC 2016 – Present Grant Writer – POLLUTION PREVENTION INSTITUTE, Manhattan, KS 2010 – Present Volunteer – BIG BROTHERS BIG SISTERS, Winfield, KS 2010 – 2017 Volunteer – UNIVERSITY UNITED METHODIST CHURCH, Fort Worth, TX 2009 – Present Goodwill Volunteer – PROJECT TRANSFORMATION, Dallas, TX 2010 – 2016 Intern – PROJECT TRANSFORMATION, Kansas City, MO and Dallas, TX 2006 – 2007

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