Supply Chain Development

Jeffrey Lewis

*** *. ***** **** #*** Long Beach, CA 90802

*************@*****.*** 478-***-****

EXPERIENCE

Liquid Technologies, Research Chemist

Chino, Feb 2013 - Sep 2013

Contract Manufacturer of Hair Care, Personal Care, OTC, Cosmetic, &

Health Care products

Specialties: Hair Fixatives, Aerosols, Pomades, Gels, Hair Dyes(permanent

& semi), Shampoo, Conditioners

. Initiate cGMP & cGLP practices in manufacturing, product dossiers to

regulatory agencies, SOP creation & implementation

. Work independently with clients to develop new products, Generate test

ideas to substantiate claims, label claims, foam tests, skin

moisturization tests

. Development of new product candidates, resolved production problems

for pigmented anhydrous products, evaluated alternate raw material

sourcing

Johnson & Johnson, Process Engineer

Los Angeles, Dec 2011 - Feb 2013

Brands: Neutrogena, Aveeno, Clean & Clear, Lubriderm, Neosporin, Cortaid,

Bengay, Roc, Johnson's, Ambi, Desitin, Piz Buin

Specialties:Wipes, OTC, Creams,Ointments, Lotions, Micro-Emulsion Gels,

Serums, Surfactants, Aerosols, Acne, Body, Foundation & Color

. Reformulation & Scale-Up / Pilot for new product and marketed product

life cycle support for semi-solids, liquids, and aerosols in

manufacturing

. Perform six - eight simultaneous lab batches without error or

precision in less than 2 hours. Extensive study on formula with

ingredient concentrations

. Lead NC/CAPA Investigations, Product Impact Assessment, Remediation,

Material Supply Chain, Business Continuity Projects, Cost Savings

. Support Materials/Quality depts. with reliability input, qualification

of safety and assessment of raw materials and finished product risk

analysis

. MWI Creation & Transfer, Test Method Validation / Process

Qualification; RDO / GCC / APR Development, Stability Studies, Raw

Material Efficacy

o Increased Sales by +$1M in reformulation: Clean Shampoo, Anti-

Residue, while reducing cost $4/kilo & initiated energy

efficient cold-process

o Redesign manufacturing processes, leading to shortened

manufacturing times and lowering plant costs, reformulate for

ease of manufacturing

o Lean Process Improvements using Open Kettle, Krieger, Becomix

MFG Kettles, cold process polymer, carbomer, and silicone

replacements

o Inclusion of 15-25% post Purified Water "Quench", Halved Process

Time, & decreasing particle size by >1/3 for Improved Product

Quality

o 6 months ahead of goal to Increase Manufacturing Units by 120M

by 2014; leveraged / streamlined Master Site Plan to Increase

Plant Capacity

Johnson & Johnson, Formulations Chemist Los

Angeles, Jan 2011 - Dec 2011

. Technical Expertise in emulsions, surfactants, liquids, aerosols,

natural/derived alternatives for New Product Development, Scale-Up, &

Reprocessing

. Work with Vendors to Obtain Clinical And Raw Material, Efficacy &

Safety Testing to be performed to support incorporation into marketed

products

. Coordinate with contract labs overseas for new product manufacturing

transfer & assess reliability; responsible for management of technical

specialists

. Perform Gap Analysis, Author / Review process descriptions, data

compilation, regulatory compliance, Conduct investigations in method

performance

. Troubleshoot manufacturing deviations to improve formula stability

while independently developing products from concept to testing to

market

. Formulated new lightweight clear micro-emulsion lotion with enhanced

active drug delivery systems which were incorporated into new line /

market

o SPF 70 lightweight, fast-absorbing anhydrous or water-based

clear lotion micro-emulsions; creative focus in market appeal

and safety / trends

o Natural and Oil-Based Hair Serum which acts as hair dye system

(Lasts 6-7 weeks), active version had gray hair growing in

natural hair color

o Bio-polymer encapsulation of active drug products to improve

trans-dermal penetration of active ingredients into the skin,

Lowers Cost

o 86% Water-Based O/W Micro-Emulsion Eye-Shadow with 2-5% Pigment;

does not crease, washes off with only water, vibrant or soft

colors

Dendreon Corporation, Manufacturing Associate II

Seal Beach, Aug 2010 - Jan 2011

Developer of Active Cellular Immunotherapy Treatment for Metastatic

Castrate Resistant Prostate Cancer

. Responsible for Aseptic Process Validation of Leukapheresis based

Antigen Therapeutics for Site Start-Up & FDA Licensure for Product

Manufacture

. ISO Class 5 Clean Room & Manufacture of Blood Therapeutics / Drug

Products including; 21 CFR Parts 58, 210-211, 600, 1270-1271. HPLC

(Empower)

. Equipment Maintenance, Calibration, IQ/OQ/PQ Validation including the

development of assays for identification & quantification of drug

active

Mckenna Laboratories, Quality Control & Assurance Chemist

San Diego, Feb 2008 - Aug 2010

Contract Manufacturer of Surfactants, Personal Care, OTC, Cosmetic, &

Health Care products

Specialties: OTC, SPF, Ointments, Lotions, Cr mes, Scrubs, Hair

Fixatives, Mascara, Surfactants, Shampoo, Conditioners

. Manage control programs (Calibration, Audit, Hazmat, Safety, Quality,

EHS) & trained native Spanish Speaking Staff on policy and mfg

procedures

. Development, Implementation, and training of manufacturing processes,

API's, & SOPs based on FDA, cGMP, cGLP, OSHA, ISO requirements

. Purified water system site validation Set-Up, & Procedures for: TOC,

Coliform, Microbiological, pH, & Heavy Metals Testing.

. Responsible for evaluating hazardous material & conduct EHS reviews

for new and existing products; conduct EHS investigations to new

processes

. Development of compliant microbiological lab for Subspecies

Identification, Anti-microbial Effectiveness testing and Growth

Promotion

o Reduced company spending of $5000-10,000 per month by

elimination of vendor and contract testing services

o Development of lab resulted in alternative cost reductions by

allowing for preservative testing to be performed by research &

development

. HPLC (Empower) / GC, UV-Vis Testing Protocols developed In-House for

OTC drug products marketed to US, Canada, Europe, Asia, Australia,

Mexico

o Reduction in Hand Sanitizer Outsource Testing cost by $1000 per

month by alternative IQ/OQ/PQ Assay Validation of ethyl alcohol

o Facilitated in Purified Water System IQ/OQ/PQ Validation;

Identified & supported customer clinical claims, Increasing site

services

R&D Chemist (concurrent) San

Diego, Dec 2008 - Aug 2010

. In-Process stability testing, process engineering, formulation

adjustments, duplicate prototype and new product development

. In-House customer / business development from conception to

formulation to pilot. Resolved key issues with scale-up, resulting in

familiarity with MFG

. Evaluated costs & feasibility for project objectives including:

efficacy, safety, key market trends, competition, and raw material

technical development

. Cost range of typical W/O emulsion lotion ($2-$29/Kilo), Incorporated

synergistic polymers to create a stabilized form of retinol in active

systems

. Focus on impact of business and raw material supply chain /

Sustainability, Focus on customer / Vendor interaction to maintain

positive relations

Invitrogen / Life Technologies, Lab Technician II

Carlsbad, Aug 2007 - Feb 2008

Developer of Protein Analysis, Marker & Identification Kits, PCR assays,

Oligonucleotides, and Drug Development Reagents and Inhibitors

. Protein Assays (Affinity, Gel Filtration, HPLC (Agilent), FPLC, RPLC,

ION Exchange), assist in production of specialized DNA/RNA indicators

. Analytical Assay Development (SDS-Page, UV-Vis, FT-IR, Native Page,

ELISA, Western Blot, Bradfords, BCA, DCA) for reagent kit production

. Provided NPI QA support to product commercialization process teams,

sustaining engineering, & Technical management, and customers

. Formulations & stability development for Clinical glycosylzed protein

variants (lyophilized & solution); Aseptic Techniques & Cell Culture

. Analytical method development, Technical assurance / Transfer to

Manufacturing, & Troubleshoot technical support for individualized

clientele

. Organized & developed a system to track multifunctional departments'

work orders, product inventory, batch Records, material database, and

MWI's

Celgene / Signal Pharmaceuticals, Research Assistant II

La Jolla, May 2006 - Jun 2007

Drug Developer for Multiple Myeloma, Erythema Nodosum, ADHD, and Thyroid

Cancer

. Assisted with lead identification, design, & execution of In-Vivo

Phase 3 Trials, supported Oncology, Analytical, & Biochemistry

Departments

. STR Cell Culture and Fermentation (SF9/SF21); Media Reagent Prep,

Plating, Staining, Aseptic technique, Drug sterility, Environmental

Monitoring

EDUCATION University of San Diego, BA, Areas of Focus: Spanish &

Biochemistry Aug 2003 - May 2007

LANGUAGES, SPECIAL SKILLS, AND COMMUNITY ACTIVITIES

. Fluency in Spanish Written & Spoken; Proficient in French, Portuguese;

First Aid Certified Through Red Cross (May 2014), Eagle Scout 2000

. (Microsoft Office, Excel, Powerpoint, Access, SAP, Agilent, Web

Design, Flash, Adobe, Quickbooks, Mini-Tab, Linux, Oracle 8i, Java, C,

C++

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