Experience

Taysha Gene Therapies

• United States
• Biotechnology
• 1 - 100 Employee

• Clinical and Commercial Supply Chain Consultant

  • Apr 2023 - Present

  Dallas, Texas, United States ● Develop and oversee the clinical supply strategy for various clinical programs in the US, UK, and Canada, including labeling, distribution, and vendor management. ● Responsible for the global sourcing and distribution of ancillary supply components for dosing. ● Collaborates with CMC, Clinical Development, Regulatory, and Clinical Operations to develop Pharmacy Manuals and SOPs in support of Taysha clinical programs. ● Manages vendors and service providers along with Procurement… Show more ● Develop and oversee the clinical supply strategy for various clinical programs in the US, UK, and Canada, including labeling, distribution, and vendor management. ● Responsible for the global sourcing and distribution of ancillary supply components for dosing. ● Collaborates with CMC, Clinical Development, Regulatory, and Clinical Operations to develop Pharmacy Manuals and SOPs in support of Taysha clinical programs. ● Manages vendors and service providers along with Procurement and QA to ensure expected outcomes are achieved within budget. Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Director, Clinical Supply Management

  • Nov 2021 - Apr 2023

  East Hanover, New Jersey, United States ● Oversees clinical supply vendor management, including contract and agreement reviews, KPI tracking, and process improvement for contracted CMOs and IRT vendors. ● Manages vendor relations across multiple line functions, including clinical research scientists and QA. ● Initiates and leads audits together with GMP QA and GCP QA to assess vendor capabilities. ● Initiates working practices and SOPs as applicable. Streamlines existing processes with QA and other line functions to… Show more ● Oversees clinical supply vendor management, including contract and agreement reviews, KPI tracking, and process improvement for contracted CMOs and IRT vendors. ● Manages vendor relations across multiple line functions, including clinical research scientists and QA. ● Initiates and leads audits together with GMP QA and GCP QA to assess vendor capabilities. ● Initiates working practices and SOPs as applicable. Streamlines existing processes with QA and other line functions to promote continuous improvement. ● Contributes to protocol and pharmacy manual development based on drug product specifications and technical instructions for use. ● Conducts quarterly business review meetings with all approved vendors. ● Performs all responsibilities of the Senior Clinical Supply Manager (below). Show less



Novartis Oncology

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Drug Supply Manager

  • Nov 2017 - Nov 2021

  East Hanover, New Jersey ● Single point of contact for the supply and inventory management of 15 compounds for clinical use in US Phase I-IV and Investigator-Initiated Trials (IITs). ● Forecasts drug demand with Supply Chain Management based on clinical enrollment and dosing strategy; places orders at the agreed intervals. ● Coordinates with clinical teams and contract manufacturers to arrange for the randomization, packaging, labeling, and distribution of clinical supplies per the approved study design, internal… Show more ● Single point of contact for the supply and inventory management of 15 compounds for clinical use in US Phase I-IV and Investigator-Initiated Trials (IITs). ● Forecasts drug demand with Supply Chain Management based on clinical enrollment and dosing strategy; places orders at the agreed intervals. ● Coordinates with clinical teams and contract manufacturers to arrange for the randomization, packaging, labeling, and distribution of clinical supplies per the approved study design, internal procedures, and GxP requirements. ● Oversees all vendor packaging activities from RFP to work order creation, label design, review and approval of batch records, and monitoring of scheduled work against agreed timelines. ● Ensures supply availability for “Compassionate Use” in named-patient or expanded access programs Show less



Caligor Coghlan

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Vendor Assurance / Quality System Manager (US)

  • Nov 2016 - Nov 2017

  Secaucus, NJ ● Responsible for the application of a GDP/GMP compliant Quality Management System in support of global clinical sourcing and distribution activities at Caligor US. ● Work with global team members throughout the clinical supply chain to ensure ethical, bona fide product procurement and regulatory-compliant distribution to authorized entities. ● Investigate product quality complaints, including temperature excursions in transit, to determine product quality impact and fitness for use based… Show more ● Responsible for the application of a GDP/GMP compliant Quality Management System in support of global clinical sourcing and distribution activities at Caligor US. ● Work with global team members throughout the clinical supply chain to ensure ethical, bona fide product procurement and regulatory-compliant distribution to authorized entities. ● Investigate product quality complaints, including temperature excursions in transit, to determine product quality impact and fitness for use based on product-labeled storage conditions and available stability data. ● Perform internal audits of Caligor processes to assess procedural compliance and facilitate continuous improvement of operations across US and UK sites. ● Host client and regulatory audits of the US facility. ● Perform external GDP/GMP qualification audits of suppliers and third party GxP service providers. Show less



Covance

• United States
• Research Services
• 700 & Above Employee

• Drug Supply Specialist

  • Jun 2016 - Nov 2016

  Princeton, NJ ● Support the global clinical supply chain from sourcing through distribution, drug return, accountability, and destruction by managing third party vendors on behalf of the study sponsor. ● Develop labels for IMP/NIMP according to local requirements for global studies, coordinate the translation and approval of label text, create label mock-ups for submission to authorities. ● Manage the importation and exportation of Clinical Trial Supplies via coordination of required documentation to… Show more ● Support the global clinical supply chain from sourcing through distribution, drug return, accountability, and destruction by managing third party vendors on behalf of the study sponsor. ● Develop labels for IMP/NIMP according to local requirements for global studies, coordinate the translation and approval of label text, create label mock-ups for submission to authorities. ● Manage the importation and exportation of Clinical Trial Supplies via coordination of required documentation to the appropriate parties for submission to authorities. ● Develop study-specific Clinical Trial Supply Plans, site documentation, and status spreadsheets in close collaboration with study teams. Show less



Xerimis

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QA Manager

  • Apr 2014 - Jun 2016

  Moorestown, NJ - Oversee Quality Control Inspectors and the inspection of clinical packaging. - Work on interdepartmental teams to investigate nonconforming product and non-compliant events. - Oversee the tracking of non-compliant event and CAPA reports through completion and the maintenance of associated metrics. - Verify batch record release documentation and perform the release of clinical supplies. - Maintain inventory of retain samples for Clinical Trial Material (CTM). - Perform risk… Show more - Oversee Quality Control Inspectors and the inspection of clinical packaging. - Work on interdepartmental teams to investigate nonconforming product and non-compliant events. - Oversee the tracking of non-compliant event and CAPA reports through completion and the maintenance of associated metrics. - Verify batch record release documentation and perform the release of clinical supplies. - Maintain inventory of retain samples for Clinical Trial Material (CTM). - Perform risk assessments of functional areas and activities. - Author or approve Standard Operating Procedures to ensure compliance with GMP regulations.

• Operations Specialist, Distribution

  • Apr 2013 - Apr 2014

  Moorestown, NJ - Prepare shipment documentation for IXRS requests of Clinical Trial Material (CTM) to clinical sites. - Audit and approve shipment documentation packets prior to pulling and packing CTM for shipment. - Track shipment status and maintain databases of CTM inventory and shipment history. - Provide support throughout operations while identifying deficiencies in training and procedures. Work with Operations Manager, VP of Operations, and QA to develop creative solutions. - Revise… Show more - Prepare shipment documentation for IXRS requests of Clinical Trial Material (CTM) to clinical sites. - Audit and approve shipment documentation packets prior to pulling and packing CTM for shipment. - Track shipment status and maintain databases of CTM inventory and shipment history. - Provide support throughout operations while identifying deficiencies in training and procedures. Work with Operations Manager, VP of Operations, and QA to develop creative solutions. - Revise SOPs and implement changes through effective training and education of personnel.



Integra LifeSciences

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Product Release Specialist

  • Jun 2012 - Apr 2013

  Plainsboro, NJ - Review product batch records to ensure documentation is accurately maintained in accordance with corporate policies and GMP standards. - Inform and educate personnel when outside of GMP compliance. Monitor types of documentation errors observed to facilitate additional training efforts, when needed. - Prepare certifications for product release to customers and OEM partners. - Assist in reporting, managing, and tracking non-conforming product investigations and CAPAs. -… Show more - Review product batch records to ensure documentation is accurately maintained in accordance with corporate policies and GMP standards. - Inform and educate personnel when outside of GMP compliance. Monitor types of documentation errors observed to facilitate additional training efforts, when needed. - Prepare certifications for product release to customers and OEM partners. - Assist in reporting, managing, and tracking non-conforming product investigations and CAPAs. - Communicate with interdepartmental personnel the pending requirements of future product releases. Show less



Xerimis

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Multiple Positions within Operations and Quality

  • Mar 2010 - Jun 2012

  Moorestown, NJ 8/2011-6/2012 Quality Control Associate - Verify staged clinical trial kit components against the Batch Record Bill of Materials. - Provide packaging room clearance for drug product per SOPs and environmental specifications. - Perform in-process inspections to ensure packaging is proceeding according to client special instructions, drug specifications, and SOPs. - Verify all returned materials are accounted for at the end of packaging activity. 3/2011-8/2011 Operations… Show more 8/2011-6/2012 Quality Control Associate - Verify staged clinical trial kit components against the Batch Record Bill of Materials. - Provide packaging room clearance for drug product per SOPs and environmental specifications. - Perform in-process inspections to ensure packaging is proceeding according to client special instructions, drug specifications, and SOPs. - Verify all returned materials are accounted for at the end of packaging activity. 3/2011-8/2011 Operations Staging Associate - Prepare clinical trial kit components for packaging Batch Records per SOPs, GMPs, and client special instructions. - Ensure the drug product to be used has been properly maintained and is released by QA. - Notify Project Management of any issues with packaging materials and coordinate solutions. - Generate Quarantine Status Tags for proper storage and release of finished clinical product. 3/2010-3/2011 Clinical Packaging Room Supervisor - Initiate and oversee the packaging and labeling of solid dosage form product in accordance with SOPs, GMPs, and client special instructions. - Maintain a clean working environment to prevent contamination of drug product during packaging. - Ensure finished product meets Quality Control standards. - Accurately document completed procedures on the Batch Record and account for drug product 100%. Show less