Josh Callahan Email and Phone Number
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Experienced Clinical Supply Manager working in Supply Chain Labeling and Logistics. Familiar with IxRS and Inventory Management systems for IMP/drug distribution to global clinical trial sites, while adhering to local import/export regulations. Meticulous attention to detail with strong organization skills and first time quality mindset. Bachelor’s Degree in Biology from University of Massachusetts, Lowell.
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Sr. Manager, Cmc Ctm Logistics And MaterialsOra, Inc.Durham, Me, Us
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Sr. Manager, Cmc Ctm Logistics & MaterialsOra, Inc. Mar 2021 - Nov 2024Andover, Massachusetts, Us -
Clinical Trial Materials Labeling & Logistics ManagerOra, Inc. Mar 2019 - Nov 2024Andover, Massachusetts, Us
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Labelling CoordinatorOra, Inc. Nov 2018 - Mar 2019Andover, Massachusetts, UsPlan, forecast, and coordinate activities and resources in support of multiple aspects of clinical trial supply management.
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Senior Clinical Supply SpecialistParexel Mar 2017 - Nov 2018Durham, North Carolina, Uso Support Clinical Supply Leaders with the sourcing and distribution strategy for Clinical Trial Supply and Logistics across multiple projectso Supports the Clinical Trial Supply and Logistics teams by applying and executing supply chain to achieve client satisfaction and delivery of projects /programs on time, to budget, to the highest quality and in compliance with ICH GCP and GxP.o Monitor inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issueso Keeps up to date with study scope and progress to ensure that study/project timelines and budgets are met in accordance to the contractual agreement including proactive management and communication of any changes and/or risks.o Review clinical trial protocols and understand impact to identify demand assumptions based on enrollment rate, number of sites, number of countries, etco Assist with Master Batch Record, as well as label development and management for clinical producto Coordinate IMP labeling and lab kit productions based on project timelines and needso Communicate and update clinical supply requirements to supply chain project leads and ensure seamless coordination of demand and supplyo Communicate with third party providers and negotiate scope of work and timelineso Request and review quotes from providers -
Sr. Quality SpecialistParexel Dec 2014 - May 2017Durham, North Carolina, Uso Act as Interim Head of Quality Control when needed and performed such daily tasks as: -Review Master Batch Records and QC Inspection forms to ensure GDP and GMP compliance -Release of material into inventory from quarantineo Provide Quality consultancy to Operations personnelo Execute quality control checks of medicinal products, medical devices, in-vitro diagnostics and other clinical trial supplies during receipt and distribution, as well as in-process quality control checks during production and labelling to ensure GMP complianceo Led controlled document revision project to lean out QC inspection forms o Work closely with multiple departments daily to meet timelines and ensure customer satisfactiono Facilitate process improvement opportunities by creating controlled document: a QC Failure Tracker, which was implemented globally and used to run metrics to identify trendso Analyze and run metrics to identify process trends and gaps to be improved upono Process change implemented via Change Control and hosting global meetings using metrics to reduce amount of In-process control QC checks during production runso Involved in the temperature-mapping validation of the 50,000 sq ft North America Distribution Center for both Winter and Summer qualifications in 2016. •Review OQ/PQ protocol documents before execution •Execute testing and data analysis according to validation protocols (OQ/PQ) for each temperature controlled area(15-25C controlled ambient, 2-8C,-20C) with support of Head of Quality Control and GMP Lead to ensure compliance with regulatory o Review and revise SOPs, Controlled Documents, Risk Assessments, Deviations and Quality Issues/ CAPAso Provide training and mentoring to new staff members
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Field SupervisorPeterson Party Center Mar 2009 - Aug 2013Woburn, Ma, Us-Oversee up to 10 crew members to ensure orders and deliveries are met on time -Liaison with customers to ensure satisfaction and requests are met in a timely fashion for events-Act as Man on Premise during events as main point of contact to trouble shoot any equipment issues-Run heavy machinery (forklifts, lulls, jackhammers) -
In-Seat Service CoordinatorAramark Refreshment Services Apr 2008 - Sep 2008Philadelphia, Pennsylvania, Us2008 Season-Oversee in-seat service kitchen area consisting of staff of 10+ food runners, 5+ drink runners, 1-2 bartenders and 3-5 line cooks to ensure kitchen operating smoothly and orders are being met in a timely fashion-Keep kitchen in an inspection ready state at all times-Daily inventory control-Daily cash outs -
Grocery ClerkAlbertsons Sep 2004 - Apr 2008Boise, Idaho-Ran frozen food department for last year of tenure. In charge of ordering stock, receiving, inventory, building end-cap displays according to weekly flyer specials.-Helped out across multiple departments: grocery stock, cashier, customer service, shipping and receiving-Ensure cash drawer always accurate at end of shift-Use of forklifts and electric pallet jacks
Josh Callahan Skills
Josh Callahan Education Details
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University Of Massachusetts LowellGeneral -
California State Polytechnic University-PomonaGeneral
Frequently Asked Questions about Josh Callahan
What company does Josh Callahan work for?
Josh Callahan works for Ora, Inc.
What is Josh Callahan's role at the current company?
Josh Callahan's current role is Sr. Manager, CMC CTM Logistics and Materials.
What is Josh Callahan's email address?
Josh Callahan's email address is jo****@****xel.com
What is Josh Callahan's direct phone number?
Josh Callahan's direct phone number is +133997*****
What schools did Josh Callahan attend?
Josh Callahan attended University Of Massachusetts Lowell, California State Polytechnic University-Pomona.
What skills is Josh Callahan known for?
Josh Callahan has skills like Standard Operating Procedure, Gmp, Quality Assurance, Pharmaceutical Industry, Clinical Trials, Validation, Clinical Research, Sop, Quality Control, Supply Chain Management, Inventory Management, Distribution Logistics.
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