Leanne Smith Email & Phone Number

United States

Carlsbad, California, United States

Dedicated, with over 15 years experience helping people achieve the American Dream of home ownership. As an experienced real estate investor, I understand crucial priorities when selecting investment property. I am also a Certified Distressed Property Expert, CDPE and can help guide you through the financial and emotional prospect of foreclosure. I have worked with banking institutions, providing Broker Price Opinion (BPO) and management of Real Estate Owned (REO) properties.

Socal

Orange County California

With over 14 years of experience as a Licensed Realtor in California, I well understand the current real estate market. I'm eager to help people with buying and selling their home, investment property or commercial real estate property. Striving to be of excellent service to my clients; so they get the most up-to-date listings and real estate information, providing crucial information on prospective properties while negotiating the best possible deals for my clients!

Virtual = It'S Everywhere!

My goal is to provide clear and timely communication as well as to assist our clients in any way I can. I further develop our business through strong relationships with clientele, Realtors, and industry professionals. I generate contracts, marketing materials, scheduling, databases, pricing, accounts payable and receivable, documentation, and record keeping. Competent in 3D Software, Femto-Tech Radon Detectors, Water Quality Testing in addition to standard office software and equipment.

• Dedicated, responsible Associate Scientist with over 15 years experience in research, process development and cGMP manufacturing.• Ability to direct complex projects from concept to fully operational status.• Diverse skills across a wide range of variously scaled fermentation, purification, formulation, fill and finish processes. • Exceptional abilities include successful and reliable manufacturing of parenteral drug products. • Principal strengths include expertise in cGMP manufacturing of clinical products, supervision of personnel and management of a cleanroom facility.• Proven ability to work in unison with staff to produce high quality biopharmaceuticals.Experience At Allergan:• Set up and managed Environmental Monitoring Program for Biological Safety Level 3 Facility• Researched, set up and managed contracts for facility security system, BSL 3 gowning, decontamination and cleaning• Trained and supervised personnel in Environmental Monitoring activities of BSL-3 Facility• Supervised cleaning and decontamination personnel for BL-3 Facility and research labs • Team member for successful execution of over 150 fermentation development runs• Developed alternative method of clarification & sterile filtration of toxic fermentation culture • Purified neurotoxin protein at various scales• Set up and equipped new Biological Safety Level (BSL) 3 Purification Lab• Set up, installed and managed safety program for new BSL 3 Facility• Developed fermentation and purification for cGMP manufacture• Validated analytical methods & qualified on ELISA assay for intradepartmental transfer • Wrote, reviewed and trained on SOPs for Purification, Fermentation & Environmental activities• Executed IQ/OQ/PQ protocols for validation of fermentation, purification & utility labs • Originated, utilized and maintained cGMP documentation (MBRs, SOPs, Logs)

Performed small scale contract fill and finish of drug products.

Associate Scientist 1992 - 1999• Developed purification, formulation and fill processes for cGMP manufacture• Managed cGMP cleanroom facility (2000 sq. ft.) and activities therein• Scaled processes and equipment from research to pilot then up to manufacturing scale• Responsible for scheduling and coordination of interdepartmental processing of drugproducts through manufacturing pipeline and quality systems• Manufactured Bulk Drug Substance, Bulk Drug Product and Placebo parenteralsto supply in Phase I, Phase II and Phase III clinical trials• Originated, utilized and maintained cGMP documentation (e.g. MBRs, logs, SOPs)Senior Research Associate 1994-1998• Researched and developed variously scaled purification, formulation and fill processes with large-scale cellular disruption, filtration and chromatography methods• Purified enzymes, proteins, peptides, antibodies and carbohydrates at various scales• Analyzed in-process samples by HPLC, TLC and SDS PAGE gel, BCA assays• Cross trained in fermentation, formulation and filling protocols and equipment• Manufactured cGMP clinical, parenteral, drug products• Supervised contract fill personnel formulating and vialing our cGMP productsResearch Associate 1992 - 1994• Designed process equipment necessary to purify and formulate parenteral drug• Purified proteins, peptides and carbohydrates in developmental stages• Formulated, vialed and analyzed stability and toxicology drug study samples

GMP Production Associate and Supervisor • Supervision of 5 manufacturing personnel within regulated cGMP cleanrooms• Initiated and maintained extensive computer database to track cGMP manufacturing runs• Process development of purification, formulation and fill methods• Purified gram to kilogram quantities of growth factors for cGMP products• Ran analytical methods and then worked with QA to validate those methods• Originated and maintained cGMP documentation (MBRs, SOPs, Logs)• Interdepartmental coordination and scheduling of cGMP manufacturing runs

Mountain View, Ca

Senior Research Associate 1989 - 1990• Assisted in scaling-up purification scheme, from research to semi-preparative scale• Used wide variety of equipment for research, pilot, manufacturing scaled processesResearch Associate 1986 - 1989• Responsible for HPLC and FPLC laboratory and 7 systems therein• Purified several proteins, two used in crystallographic studies (See publications below)• Researched and developed an assay for detection, quantification & activity of protein• Co-Author on 3 scientific articles in major publications.