Justin T. Malone, Ms, Cqa

Justin T. Malone, Ms, Cqa Email and Phone Number

Head of US Quality Assurance @ Apollo Therapeutics
New York, NY, US
Justin T. Malone, Ms, Cqa's Location
New York City Metropolitan Area, United States, United States
Justin T. Malone, Ms, Cqa's Contact Details
About Justin T. Malone, Ms, Cqa

Biopharmaceutical professional with experience from Inoculum preparation to bioreactor operations and medical devices in cGMP environments. Attained my Masters degree in Leadership and Stragetic Management at Manhattanville College to advance my career through management.I would like to use my strong interpersonal skills and public speaking ability to further advance my career.Specialties: cGMP, Large Scale Manufacturing (LSM), Clinical Scale Manufacturing (CSM), Aseptic techniques,Medical Devices, SAP, Production Deadlines, Raw material implementation and ordering, Writing/Editing/Reviewing of Master Batch Records (MBRs) and Standard Operating Procedures (SOPs), implementation/closure of CAPAs and Environmental monitoring of cleanrooms.

Justin T. Malone, Ms, Cqa's Current Company Details
Apollo Therapeutics

Apollo Therapeutics

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Head of US Quality Assurance
New York, NY, US
Employees:
61
Justin T. Malone, Ms, Cqa Work Experience Details
  • Apollo Therapeutics
    Head Of Us Quality Assurance
    Apollo Therapeutics
    New York, Ny, Us
  • Justvend Llc
    Chief Executive Officer
    Justvend Llc May 2024 - Present
    Providing the best selection in vending since 2024. Our machines are located in high-traffic areas, making it easy for customers to grab their kids a quick toy. We’re committed to providing the highest level of service and products to our customers
  • Izju Travels Incorporated
    Chief Executive Officer/Founder
    Izju Travels Incorporated May 2024 - Present
    Providing customers with easy travel experiences. Cars, travel plans and vacation rentals (coming soon) are all part of our customer experience.
  • J.T. Malone Enterprises
    Principal Consultant
    J.T. Malone Enterprises Oct 2022 - Present
    Providing clients with technical and quality assurance support. Primary focus is on remediation activities, audits, change control management, investigations, batch records (creation & reviews), Quality leadership and project management activities.Represents clients as QPIP (Quality Person in Plant) for Phase 1b to Commercial drug substance and drug product run.
  • Black Diamond Networks
    Us Quality Assurance
    Black Diamond Networks Dec 2022 - Mar 2023
    Andover, Massachusetts, Us
    • Review and approve MBR, SOPs, EBRs, TTPs, Validation reports and other related documents• Provide quality oversight of activities performed by 3rd Parties or suppliers (i.e., Audit adherence; Quality Agreements), as required by applicable internal Standards and Regulatory authorities• Authoring, reviewing, approving, and maintaining Standard Operating Procedures• Dispositions large molecule products• Reviews and approves all internal and vendor deviations, change controls & CAPAs
  • Avalo Therapeutics
    Associate Director Quality Assurance
    Avalo Therapeutics Feb 2022 - Jan 2023
    Rockville, Maryland, Us
    • Schedules and preforms vendor & internal audits as Lead Auditor• Review and approve MBR, SOPs, EBRs, TTPs, Validation reports and other related documents• Track, review and approve deviations (internal/external) and OOSs • Author, review, approve audit plans, conduct audits at 3rd party vendors and issuance of audit findings• Quality Person in Plant duties as needed • Functional Quality Lead on multiple small and large molecule products• Provide quality oversight of activities performed by 3rd Parties or suppliers (i.e., Audit adherence; Quality Agreements), as required by applicable internal Standards and Regulatory authorities• Authoring, reviewing, approving, and maintaining Standard Operating Procedures• Dispositions small and large molecule products
  • J.T. Malone Consulting Llc
    Principal Consultant
    J.T. Malone Consulting Llc Jan 2016 - Oct 2022
    Providing clients with technical and quality assurance support. Primary focus is on remediation activities, audits, change control management, investigations, batch records (creation & reviews) and project management activities.
  • Wuxi Biologics
    Director Of Quality Management Systems And Compliance
    Wuxi Biologics Dec 2021 - Mar 2022
    Wuxi, Jiangsu, Cn
    -Oversees deviation, change controls and CAPA management-Chair of Change Control Review Board-Hosts and schedule all client audits-Manages outcomes from client audits-Lead auditor for vendor and supplier audits-Authors Quality Agreements -Chair of monthly Quality Council Meeting -Oversees all document control via MasterControl
  • Wuxi Biologics
    Associate Director Quality Assurance
    Wuxi Biologics Jan 2021 - Dec 2021
    Wuxi, Jiangsu, Cn
    -Review and approve QA documents including SOPs, Change Controls, URS, FAT, SATs, various protocols-Schedules & performs vendor audits -Head of Vendor Management program -Works cross functionally to ensure manufacturing will be completed on time -Ensures all manufacturing activities are completed using cGMP-Leads investigations within manufacturing area-Leads team of QA specialist that are responsible for recording QA observations during the manufacturing process-QA Functional Lead for various PD and Clinical cGMP products
  • Celgene
    Senior Project Manager, Global Pharmaceutical Development And Operations
    Celgene Sep 2019 - Jan 2021
    Summit, New Jersey, Us
  • Akorn
    Lead Investigator
    Akorn Jun 2019 - Sep 2019
  • Aegerion Pharmaceuticals Limited
    Manufacturing Sme
    Aegerion Pharmaceuticals Limited Feb 2019 - Jun 2019
  • Amicus Therapeutics
    Senior Manager, Product Disposition, Biologics
    Amicus Therapeutics Oct 2016 - Feb 2019
    Princeton , Nj, Us
  • Amicus Therapeutics
    Gmp- Qa Batch Records Review Manager
    Amicus Therapeutics Apr 2016 - Oct 2016
    Princeton , Nj, Us
  • Kaztronix Llc (G&W Labs)
    Technical Investigation Writer
    Kaztronix Llc (G&W Labs) Dec 2015 - May 2016
    Arlington, Virginia, Us
  • Shire
    Product Release Specialist-Qa
    Shire Jun 2014 - Dec 2015
    Tokyo, Jp, Jp
    •Received “Operational Excellence Award” for helping successfully launch Revestive in European market•Member of Natpara Launch Team; team successfully launched and supplied product ahead of projected schedule•Managed five Contract Manufacturer Organizations (Domestic and International) to ensure timely release of products•Audited data for company’s IND reports•Member of team that co-authored current SOP on “Disposition of Clinical and Commercial Products”•Review of Batch Records and/or Device History Records (DHRs) to verify calculations, product accountability, accuracy and proper GMP documentation practices and prepare them for final review and product release as per NPS requirements
  • Shire
    Quality Specialist-Consultant (C&G Consulting)
    Shire Mar 2014 - Jun 2014
    Tokyo, Jp, Jp
    •Review of Batch Records and/or Device History Records (DHRs) to verify calculations, product accountability, accuracy and proper GMP documentation practices and prepare them for final review and product release as per NPS requirements•Manage process of tracking errors in Batch Records and/or DHRs and report to management of any inconsistencies•Work with quality counterparts at CMO’s to resolve issues related to batch record and/or DHRs review•Prepares appropriate documentation for final disposition process of NPS products•Review of all lot associated deviations, CAPAs and change controls
  • Spectraforce Technologies
    Contractor- Quality Document Review Specialist For Merck Spo Quality Group
    Spectraforce Technologies Jun 2013 - Apr 2014
    Duties include reviewing all production vaccine batch records for SPO (Sterile Production Operations). Ensuring all production batch records adhere to federal and international guidelines. Initiating EN (Event Notifications) for non-conformances and deviations. Working closely with operators, leads and supervisors to ensure timely comment resolution for batch records. Approving and entering lot related information into SAP and Trackwise.
  • Medtronic Spine & Biologics
    Manufacturing Supervisor (Grafton Bone Graft)
    Medtronic Spine & Biologics Jan 2013 - Apr 2013
    Minneapolis, Mn, Us
    Supervision over multiple manufacturing associates and seven Grafton product lines.Providing career guideline to manufacturing associates. Ensuring all cGMP guidelines are understood and followed.Ensuring all raw materials are stocked and within expiry dates. Ensuring all production deadline are met in accordance with financial forecast. Entering/Planning/Edit production lots within SAP system. Second shift emergency response site leader.Working closely with Engineering, QA,QC,Maintenance, Packaging & Shipping and Planning groups to ensure all products are within specification for release.
  • Medtronic Spine & Biologics
    Manufacturing Supervisor (Magnifuse Bone Graft)
    Medtronic Spine & Biologics Jun 2012 - Apr 2013
    Minneapolis, Mn, Us
    Supervision over multiple manufacturing associates.Providing career guideline to manufacturing associates. Ensuring all cGMP guidelines are understood and followed.Ensuring all raw materials are stocked and within expiry dates. Ensuring all production deadline are met in accordance with financial forecast. Entering/Planning/Edit production lots within SAP system. Second shift emergency response site leader.Working closely with Engineering, QA,QC,Maintenance, Packaging & Shipping and Planning groups to ensure all products are within specification for release.
  • Laureate Pharma
    Scientist (Shift Lead)
    Laureate Pharma Oct 2011 - Jun 2012
    Responsible for development, optimization, implementation and validation of cGMP methods for mammalian cell-derived biopharmaceutical products. Conducts the implementation of production procedures to optimize manufacturing processes and regulatory requirements. Assist process development in developing scalable processes with improved product yield and reduced costs for manufacturing systems. May research and implement new methods an technologies to enhance operations. Work on extreme complex problems where analysis of situations or data requires an evaluation of intangible variables. Excercise independent judgement in developing methods, techniques and evaluation criteria for obtaining results. Act independently to determine methods and procedures on new projects and manage the activities of other junior scientists
  • Progenics Pharmaceuticals
    Associate Manufacturing Scientist
    Progenics Pharmaceuticals Mar 2010 - Sep 2011
    New York, New York, Us
    Duties include scheduling cell expansion activities, setting up production bioreactors for SIP (Steam In Place) and CIP (Clean In Place), performing SIP and CIP operations, ordering Upstream Manufacturing supplies, daily monitoring of MCB (Master Cell Bank), performing raw material implementation planning for PSMA mAb (GS CHO cell line), scheduling PMs (Preventive Maintenance) and maintenance contracts for Vi-Cell and Nova Bioprofile Analyzer, writing and reviewing SOPs and Batch Records
  • Progenics Pharmaceuticals, Inc
    Assistant Manufacturing Scientist
    Progenics Pharmaceuticals, Inc Feb 2008 - Mar 2010
    Duties include media preparation and inoculum preparation, performing vial thaws, daily samples and media additions on CHO cell line daily monitoring of freezer and cold box temperature charts, monthly environmental monitoring of clean rooms, post testing of media preparation filters, performing daily, monthly and semi-annual cleans of BSC (Biological Safety Cabinet), performing static environmental monitoring, preparing sterile tubing assemblies, writing and revising of Manufacturing Batch Records and SOPs, writing change controls , preparing GMP samples for QA testing, monitoring raw material usage in manufacturing area, assisting in the start of a new cell line/ product (PSMA Campaign)
  • Amgen West
    Manufacturing Associate
    Amgen West Jan 2006 - Oct 2007
    Duties include sampling product to monitor for contaminations, setting up production vessels for SIP's (Steam In Place) and CIP's (Clean In Place), performing SIP's and CIP's, calibrating pH and DO probes and various other lab equipment, pre/post-testing of production filters, decommissioning of production equipment

Justin T. Malone, Ms, Cqa Education Details

  • Villanova University
    Villanova University
    Applied Project Management
  • Manhattanville University
    Manhattanville University
    Leadership And Strategic Management
  • Temple University
    Temple University
    Biology

Frequently Asked Questions about Justin T. Malone, Ms, Cqa

What company does Justin T. Malone, Ms, Cqa work for?

Justin T. Malone, Ms, Cqa works for Apollo Therapeutics

What is Justin T. Malone, Ms, Cqa's role at the current company?

Justin T. Malone, Ms, Cqa's current role is Head of US Quality Assurance.

What is Justin T. Malone, Ms, Cqa's email address?

Justin T. Malone, Ms, Cqa's email address is jm****@****ail.com

What is Justin T. Malone, Ms, Cqa's direct phone number?

Justin T. Malone, Ms, Cqa's direct phone number is +120321*****

What schools did Justin T. Malone, Ms, Cqa attend?

Justin T. Malone, Ms, Cqa attended Villanova University, Manhattanville University, Temple University.

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