Jp P. Email & Phone Number

United States

Hatboro, Pennsylvania, Us

Method Introduction & Support for Major Pharmaceutical Manufacturing ClientsAnalytical Instrument Lifecycle ManagementAnalytical Equipment IQ/OQ/PQ ManagementProcess Mapping Development Quality Management System/Application AdministrationProject Management Support - eAGILE

• Development and implement QMS for manufacturing facilities and testing laboratories serving various manufacturing industries including nutraceuticals/dietary/supplement, medical device, and food/cosmetic industries. • Managed commissioning, qualification, and validation of analytical equipment from, but not limited to: Agilent, Thermo-Fisher, Waters, Shimadzu, Bruker, Perkin-Elmer, and BioMerieux. • Managed the audit/assessment of systems in compliance to ISO 17025/9001, Title 21 CFR Part 11, 111, 210 and 211.

Lansing, Michigan, Us

• Primary responsibility includes facility design, CQV of applicable equipment including CSV (ie. LIMS), and implementing the overall cGLP operation of corporate laboratories. • Direct the implementation of turn-key processes to design and build fully compliant state licensed laboratories with procedures to manage high throughput operations (e.g. MSOs). • Method development and optimization on Agilent HPLC, GCFID-MS, LCMS/MS, and ICP-MS instruments.

Culver City, Ca, Us

- Designed, tested and developed QMSs compliant with International Standards of accreditation bodies for method development, product processing and manufacturing departments.- Manage the ISO 17025:2017 branched-accreditation process for multiple analytical lab facilities across the nation.- Member of ASTM D37 and ACIL Cannabis Working Group to help establish nationally accepted standardized methods in the Cannabis Industry.- Developed, implemented and managed Quality Measurement Assurance program (ie CARA/PA responses) for analytical laboratories in vertically integrated cannabis manufacturing facilities.

Culver City, Ca, Us

- Direct the build of analytical laboratories/facilities to support state regulated testing of products produced and manufactured for the medicinal cannabis industry across the nation.- Spearheaded the method development, implementation and transfer of methods across a variety of analytical instruments, which include but not limited to: GCFID MS/MS, UPLC-MS, UPCC, ICP-MS, and MS-Fractionation. - Develop QMS compliant with International Standards of accreditation bodies for product development, product processing and manufacturing departments. - Manage the accreditation process for ISO 17025:2017,9001 for multiple facilities across the nation.-Manage the planning and implementation of organizational Internal Auditing for Quality and Management System.

Assay Development integration with nanotechnology and waveguide optics.-Project Manager for development of a multiplex assay for Toxicology screening designed towards a Point-of-Care device. -Development of multiplexed immunoassays with protein/DNA microarrays and optical bio-sensors.-Research and optimization of surface chemistry for immobilizing proteins and nucleic acids with the use of precision robotics/techniques.

-Managed the manufacturing, production, and departmental release of a multiplexed Luminex and MesoScale Discovery assay for clinical lab diagnostic testing (LDT) to rate the risk of CVD in patients within the next 5 years.-Continually optimized the performance and sensitivity of the 7 protein based assay for the commercialized MIRISK VP® laboratory diagnostic test kit.-Managed the development and transfer of multiplexed assay platforms from Luminex and MSD technology to a less costly, yet more precise and robust platform utilizing Quansys BioSciences technology.-Developed clinical SOPs, validation reports and product design requirements necessary for the clinical regulation and regional expansion for licensing.

Los Angeles, California, Us

•Collaborated with R&D for optimization of synthetic oligonucleotides and specifications for products using Luminex instruments. •Developed and optimized bead-based assays to target sequence specific oligonucleotide probes using hybridization and PCR techniques.•Conducted PCR experiments and amplification of gene sequences for both HLA Class I and Class II loci via gel electrophoresis.•Utilized flow analysis and complimentary software to analyze Luminex bead-based assay data.

Manassas, Va, Us

•Sales representative for Cellgro(R) products in both academic and biotech accounts.•Consulted laboratory technicians/PIs in optimizing reagents for assay development and research.•Increased product exposure/sales while withholding company reputation in a competitive field.