Jaclyn Fox Email & Phone Number

Philadelphia, Pa, Us

Clark, New Jersey, Us

Somerset, Nj, Us

• Act as the Quality Leader to support the Supply Chain and Operations department• Track and report metrics and identify trends and predictive models• Respond to and track client complaints• Oversee Site Client Audits and Monitoring visits• Support Internal and external audits• Investigate Supplier non-conformance investigations• Specification Creation and approval• Supervises the daily activities of business and technical support • Quality Reviewer of Deviations and Complaint Investigations

 Primary LIMS Administrator Maintaining procedures and Quality in Compliance all applicable federal, state, or regulatory requirements Creation and Implementation of SOP’s, Stability/Validation protocols, Raw Material specification Implementing FDA approved process for incoming inspection of Raw materials and components Actively participate in Document Control System and Change Control procedure Deviation/Non-Conformance/CAPA/Investigation Manager

Philadelphia, Pa, Us

 Maintaining procedures and Quality in Compliance with PCI management system, and all applicable federal, state, or regulatory requirements Responsible for acting as Quality representative and SME on various capital projects Review and approve validation protocols, Quality technical agreements, PM schedule reports, and machine set-up perimeters of new components Creation and Implementation of Inspection SOP’s and guidelines for all incoming material relating to pharmaceutical packaging Initiation to completion of deviations, CAPA’s, change controls, Supplier Non-conformances Actively participates in Customer and Regulatory Audits

Chesterbrook, Pennsylvania, Us

Malvern, Pa, Us

HTSMethyltransferase Assay DevelopmentTitrations/IC50HMT ProfilingKinase ProfilingDemethylase AssaysBromodomain assay development- AlphaLISA/AlphaSCREEN

Rahway, New Jersey, Us

- Served as Study Associate in the design, implementation, and analysis of data from rodent, rabbit, dog, and non-human primates GLP efficacy and toxicology studies and evaluated compound toxicity· Executed various in vivo drug dosing routes including inhalation, oral, and IV on rodent, non-rodent species, and non human primate species· Various blood collection techniques on rodent, non rodent, and non human primate species· Performed computer based analysis of chemical structures to determine potential toxicity· Authored departmental SOP’s and Protocols in accordance with GLP guidelines

Milan, It

· Developed models and optimize protocols for in vivo cancer research · Xenograft human tumor cell lines in immunocompromised mice · Evaluated radiolabeled compound target binding and efficacy via biodistribution, toxicology, saturation, dosimetry, and radiotherapy studies. Radioisotopes commonly used: 177Lu, 111In, 125I, 67Ga, 153Gd, 99Tc.· Implementation and validation of gamma imaging protocols for Biospace Measures imaging instrumentation· DNA isolation and extraction via PCR· Executed non-clinical studies via inhalation, oral by gavage, subcutaneous, lateral tail vein, intramuscular, intraperitoneal, and intracardiac methods. Perform necropsy, tissue preservation, Autoradiography, and immunohistochemistry on frozen tissue sections.· Analyzed, computed, and presented comparative preclinical and clinical data· Facilitated development of a GRP receptor targeted radio therapeutic from initial screen to Phase 1 clinical trials· Software: Proficient in Graph Pad Prism, Sigma Plot Microsoft Word, Excel, Power Point, Project, PhotoShop, and Biospace Measures imaging software

Pharmacology

Master Of Business Administration (M.B.A.), Pharmaceutical Marketing And Management

Bs, Pharmacology And Toxicology