Life Sciences Health Care

James L. Sullivan

Bossier City, LA ***** 828-***-****

********@*****.*** https://www.linkedin.comhttp://www.linkedin.com/in/firstlastname

(Medical / Clinical / Life Sciences Professional)

Naturopathic Doctor (License Retired)

Author – Medical Writer – Technical Journalist

Career Summary and Objective:

Currently looking for a full or part time position to include work-from-home opportunities to use my leadership and management skills in the medical and clinical life sciences. I want to continue to dedicate my passion and support of the current bio-evolution in the life sciences involving innovative biological applications in health care, community service, and consumer products. My entire career contributions have focused on my strengths in nature science, medical service, healing arts, professional writing, teaching, community service, public health, research data analytics and technical supervision. My acquired skills and knowledge of clinical research, medical terminology, anatomy, advanced physiology, pathophysiology, gastroenterology, pharmacology, immunology, biochemistry, nutrition, physiotherapy, clinical and physical diagnosis as a physician by trade can be easily adapted where needed. I have served as a technical consultant for a broad range of scientific research of emerging technologies, trends, products, and ingredients using global internal and external networks to drive innovation of international and domestic consumer products. My analytical and engineering experience in problem solving is broad in scope across industry disciplines such as pharmaceuticals, vitamins, food ingredients, herbal medicines, agricultural compounds, and cosmetics to meet new or currently unfulfilled needs for consumers and professionals.

Areas of Expertise: Precision Medicine & Strategic Solutions – Innovation - Leadership - Supervisory Management - Problem Solving - Health Data Management – Medical / Clinical Life Sciences – Clinical Trial Operations - Medical Writing / Editing / Authoring / Teaching – Communications – Customer Service - Business Workflow Design - EDMS (Electronic Data Management Systems {SAP, Macola, Master Control) – Supply Chain Materials Management

Personal Characteristics & Strengths: Achiever, Strategist, Competitive, Believer, Responsible, Futuristic, Optimist, Deliverer, Peacekeeper, Diplomat, Advocate, Intuitive, Confident, Compassionate, Empathetic

Industry Specific Skills

Clinical trials research experience managing and coordinating targeted protocols and testing criteria relevant to health product outcomes.

Support of clinical research teams in review of protocol documents, data reports, marketing materials, abstract studies, and other clinical trial efforts as needed.

Collaborative leader with ability to communicate effectively across multiple departmental teams with a sense of urgency with effective written, oral, and interpersonal communications to include training in support of company efforts, beliefs and positions as needed.

Critical resource for medical and scientific review for a range of company produced documents, ingredient research, marketing projects and business development opportunities.

Ability to develop scientific responses, rebuttals, and other urgent documents to include technical writing of scientific papers, posters, and journal publications.

Processing ability in technical manufacturing operations with problem solving and root cause analysis with Corrective and Preventive Action (CAPA) when needed.

Research and quality control experience in analytical chemistry isolations of pharmaceuticals, plant based natural products and their derivatives.

Experienced use of experimental design protocols for improvement of production output efficiencies.

Formulation experience of pharmaceutical, herbal and food products and their processing from laboratory benchwork to scaled up production.

Selected Career Accomplishments and Achievements

Research / Innovation

Selected specifically from R & D team using my medical background to aid in compiling research in a clinical trial pilot project monitoring development of an in-process vitamin/mineral premix formulation with aim to deliver unique and innovative dissolution properties and strengthen our position as leading brand in the marketplace.

Created new product formulations across five separate brands including Powerpoint presentations of future innovation potentials to Purchasing, QC, QA, and Brand Marketing generating ideation brainstorming for new product pipelines on a regular basis.

Supplied creative input for an innovative “Meet Your Herbs” online program of a brand website to account for traceability of herbs from “field to finished product.”

Created an international repertoire for finished product registrations in the global marketplace to align with R & D specification requirements.

Analytical / Quality Control / Quality Assurance

Supplied analytical research and quality control testing in the extraction, isolation, and approval of a proprietary drug manufacturing process leading to FDA approval of pharmaceutical Taxol anti-cancer drug.

Created heavy metal algorithm for data tracking to calculate and screen for California Prop 65 heavy metal limits necessary for finished products to be released in the marketplace.

Created a first ever raw material specification template for an in-house electronic data management system (EDMS) in co-ordination with IT.

Supplied analytical leadership experience for exploration of pharmaceutical cancer drug compounds of interest to be isolated and purified from plant-based sources.

Problem Solving

Delivered ability over and above primary duties as a research scientist to conduct a Root Cause Analysis / Corrective Action project of a leading brand in the marketplace in support of QA department.

Successful with Process Quality input into the already approved and innovative patented process for liquid herbal concentrates in vegetable cellulose capsules by preventing leakage in finished product from 20% to less than 1% in first 6 months of employment giving boost to production efficiency in support of the industry leading liquid-fill branded products.

Supervision, Training, Teaching, Coaching

Selected as a Senior Scientist leader from R & D team to hire, supervise, train and coach four temporary workers in support of developing raw material buying specifications with technical input to QC creating ~ 200 Raw Material specifications within 1 year of supervision. Due to this quick execution and turnaround of the raw material specifications timetable, I extended the project to create improvement of over eighty finished product specifications.

Conducted botanical materials quality education and training sessions to the buying department in the procurement of global supply chain materials.

Leadership

Led product development and marketing support for brands in portfolio to include Natural Vitality magnesium products, Neocell collagen beauty from within products, Rainbow Light multi-vitamin/minerals, Renew Life probiotic digestive health and Stop Aging Now with a variety of alternative and preventive health maintenance products.

Support to regulatory affairs and their challenges associated with finished product implementations to meet new advances in FDA nutrition labeling requirements.

Installed a fully equipped botanical research laboratory to include buying authentic herbarium species in co-operation of international botanists’ societies setting up cGMP identity testing to meet DSHEA-FDA guidelines.

Became a lead expert in aiding with the analysis, validation, and development of the Taxol pharmaceutical anti-cancer drug approved by the FDA including continued research of Taxol derivatives for future use.

Medical Science Authoring, Writing, Editing

Authored and published a scientific paper on “Ethanol Extraction Efficiencies of Heavy Metals from Herbs of Commerce” in the AOAC journal.

Authored and published an analytical poster for “Challenges in the Identification, Characterization, and Chemical Variations of Oregano Leaf,” AOAC journal.

Co-authored a pre-development paper for an innovative and simplified high-speed counter-current chromatography analytical testing method.

Authored and published a health guide handbook “Omega Fish Oil for Dummies,” Wiley Publishing.

Served as a medical expert with authoring of any associated legal challenges of finished products and their scientific responses in the marketplace including rebuttals and other urgent documents needed by legal requiring rapid turnaround times.

Inventory Control, Business Cost Savings

Installed a distillation concentration unit for recovering ethanol used in herbal extraction that saved the company ~ 250K in operations efficiency.

Installed a Freeze Drier and Flash Film Evaporator-Concentrator in support of the leading brand positioning of fresh freeze-dried products that allowed operations to bring in-house processing, save money from outsourcing, and improve control of in-house testing of finished products.

Supplied input to keep economic recovery goals in focus that aided corporate downsizing, inventory control, and re-organization obligations resulting in creation of one new warehouse storage and one new processing facility.

Set up and installed a QC testing lab on re-location of a new operations facility that helped move more analytical testing in-house and save costs ending outsourced testing of finished products.

Education

Doctor of Naturopathic Medicine (N.D.), National College of Naturopathic Medicine, Portland, OR., (1978 – 1980).

Bachelor of Science (BSc. Human Biology (Conjoint Biochemistry core and Naturopathic Medical Science Program), Kansas Newman College, Wichita, KS., (1973 – 1978).

Professional Experience

NUTRANEXT LLC (subsidiary of Clorox) Sunrise, FL 2011 - 2020

Research and Product Development Senior Scientist

GAIA HERBS INC., Brevard, NC 2004 – 2011

Process Quality Manager

REXALL /SUNDOWN, INC., Boca Raton, FL 1999 – 2004

Research Scientist / Technical Operations Manager

ECLECTIC INSTITUTE, INC., Sandy, OR 1996-1999

Herbal Science Processing and Technical Affairs Manager

HAUSER RESEARCH, INC., Boulder, CO 1986-1996

Natural Products Research and Development Scientist

Professional Affiliations & Achievements Timeline

Member: American Organization of Analytical Chemists (1996 – 2021), American Botanical Council (1996 – 2020), American Herbal Pharmacopoeia (2018-2020), American Society of Pharmacognosy (2008 – 2014),

Marquis “Who’s Who in Science and Engineering” Lifetime Achievement Award: Biographical recognition for scientific achievements 2001 - 2018

U.S. Patent: Axial Rx Omega 3 with Green Lipped Mussel supplement, 2018

Author: “Omega Fish Oil for Dummies,” Wiley Publishing, Natures Products, Inc., 2012

Author: “Challenges in the Identification, Characterization, and Chemical Variations of Oregano Leaf,” AOAC, 2011

Author: “Efficiencies of Heavy Metal Extraction from Herbs of Commerce.” AOAC, 2010

Co-Author: “Large-Scale Separation of Caffeic Acid Derivatives from Echinacea purpurea using a new Spiral Tubing Support for High-Speed Counter-Current Chromatography” ASP, 2009.

Botanical Associate Curator: Established herbarium lab in co-operation of international botanists’ societies, Rexall / Sundown, Inc., Boca Raton, FL., 1999-2004

FDA Certification: Microscopic Identification/Characterization of Botanicals, Washington, DC 1999

Botany/Plant Systematics: Continuing education completed at Portland State University, Portland, OR., 1998

U.S. Patent # 5,679,806: Hauser Research, Inc., Boulder, CO. Research science contribution as co-inventor for isolation and purification of isoflavones from different biomass sources of Soy and Kudzu Root plant material. Oct 1997

Taxol Pharmaceutical anti-cancer drug FDA approval contribution: Performed analytical research and quality control in the extraction, isolation, and approval of proprietary manufacturing. Hauser Research, Inc., Boulder, CO., 1996

Wellspring Health Center: Naturopathic Doctor of integrated health care, natural medicine and associated preventive therapies. Wichita Ks. 1980 – 1986. (License Retired)

Military Service

Rank: E5, UNITED STATES NAVY, San Diego, CA.

Telecommunications Radioman

Secret Clearance

Vietnam War Veteran T3x597amiQ

Contact this candidate