Vanessa Smiley Email & Phone Number

Cambridge, Massachusetts, US

Philadelphia, Pennsylvania, US

Freelance blogger as a patient advocate for sleep-disorders.net for narcolepsy and sleep apnea.

Hatboro, Pennsylvania, US

Independent Consultant for quality consulting companies.

Boston, Massachusetts, US

• Responsible for assisting with the management and maintenance of external vendors and contract manufacturing organizations (CMOs) specifically for drug substance and lipid materials associated with three lipid.
• Review over 50 documents: preclinical study reports for regulatory submissions, technical study reports, batch records, certificates of analysis (CoA) and compliance (CoC), in-process and release test methods.
• Write training presentations and review SOPs, including GxP DocuSign use and the procedure and form for shipment of GMP materials between different CMOs. Work closely with document control to provide appropriately.
• Participated and assisted the Quality team by generating CMO informational spreadsheets, task management sheets for document/batch record review, and vendor management gap assessment with a metrics tool utilizing MS.

Boston, MA, US

• Provide QA oversight and management of the cystic fibrosis (CF) and other commercial stability programs for four (4) drugs: this includes stability planning, CMO liaison for quality agreement commitments, and support.
• Perform release and reference standard data review related to CoA and product disposition
• Support QA compliance functions for electronic quality systems (eQMS) such as Veeva Vault, QDoCCs, TrackWise, SLIM and JMP data management. This includes participation as an SME and ambassador to my department for new.
• Review and approve of quality documentation such as stability data, quality events (deviations, investigations, change controls, etc.), stability plans and vendor stability protocols as well as event investigation.

Basel, CH

Basel, CH

Nutley, NJ, US

Registered Representative offering securities products and services through NYLIFE Securities LLC, Member FINRA/SIPC, A Licensed Insurance Agency

New York, New York, US

Agent licensed to sell insurance through New York Life Insurance Company.

Gaithersburg, Maryland, US

Perform quality assurance review of analytical methods and instrumentation documentation including qualifications, validations, tech transfers and other associated documentation. Assist in investigations and deviation mitigation.

Gaithersburg, Maryland, US

Write qualification protocols, SOPs and reports for analytical methods, assist in new laboratory facility setup, assist in facilitating GMP processes through documentation and sample management planning. Work on innovative new technology to improve VLP product development and characterization.Assays include: Appearance and Visual Inspection, RP-HPLC for.

Gaithersburg, Maryland, US

Perform HPLC/GC method development related to Virus Like Particle (VLP) vaccine research. Qualify chromatography methods and prepare reports. Prepare documentation for QA and Regulatory groups for product testing related to Release and Stability as well as IND filings. Test and acquire new technologies (Mass Spec/UHPLC/etc) for the application of VLP.

Gaithersburg, Maryland, US

Protein Analysis Group within the Analytical Biochemistry Group. Our group characterizes protein therapeutics using a variety of physiochemical techniques such as A280, density, etc as well as HPLC analyses.

Germantown, MD, US

Xceleron Inc is a cGLP regulated CRO company. This position involved dual functionality for Xceleron Inc. As an analyst, I prepared pre-clincal and clinical samples for analysis by accelerator mass spectrometry (AMS), which involves analysis initially by LSC, HPLC fractionation and graphitization of the samples. As the AMS technician, I was responsible for.

Gaithersburg, Maryland, US

As part of the Characterization Group in the Analytical Biochemistry Department, I worked primary on peptide mapping procedures (recombinant proteins and antibodies), utilizing various protease digests and UPLC-MS. Instruments used at the facility included: Agilent 1100/1200 HPLCs, Thermo LTQ and LTQ Orbitrap, Waters Acquity UPLCs, Waters QTOF, Waters LCT.

US

Panacea Pharmaceuticals has two main focuses of area: neurodegenerative diseases (stroke/ischemia, Alzheimer's and Parkinson's disease) and cancer. The main focus of this position was to support both areas of research. Tasks included: neuronal cell culture, apoptosis and cell toxicity assays, SDS-PAGE, HPLC, formulation stability studies, Southern and.

College Park, MD, US

Bethesda, MD, US

Youngstown, OH, US

Ms, Chemsitry/Biochemistry

Courses Taken, Regulatory Sciences

Bs, Chemistry/Biochemsitry