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Posted On: 08/01/2021 6:59:02 PM
Post# of 148908
CytoDyn posted a job description for a supply chain manager 3 days ago on Linked-in. Unless I overlooked it, it is not listed on CYDY's website under Careers - Now Hiring.
https://www.linkedin.com/jobs/view/2660103804...fMEILMZ_2E
Pharmaceutical Clinical and Commercial Supply Chain Manager
CytoDyn United States
3 days ago 48 applicants
Apply Now
Direct message the job poster from CytoDyn
Cristina De Leon
Executive Assistant to the CEO at CytoDyn
About CytoDyn Inc.
CytoDyn Inc. (the “Company”) is a publicly traded late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on the Company’s lead drug candidate, leronlimab, a novel humanized monoclonal antibody targeting the C-C chemokine receptor type 5 (CCR5) and known as entry inhibitor to Human Immunodeficiency Virus (HIV). Leronlimab is in a class of therapeutic monoclonal antibodies designed to address unmet medical needs in the areas of HIV, cancer, and immunology. With respect to HIV, the CCR5 receptor plays a key role in the ability of HIV to enter and infect healthy T-cells. With respect to cancer and immunology, the CCR5 receptor also appears to be implicated in cancer metastasis such as triple-negative breast cancer, other metastatic solid tumor cancers, graft-vs-host disease (“GvHD”), and non-alcoholic steatohepatitis (“NASH”). More recently, the Company expanded its clinical focus with leronlimab to include evaluating its effectiveness in multiple other autoimmune indications where CCR5 antagonism has shown initial promise, as well as a therapy against COVID-19 disease and COVID-19 long hauler symptoms. The Company targets leronlimab treatment as a therapy for patients who experience respiratory complications as a result of contracting COVID-19. The Company believes leronlimab provides therapeutic benefit by enhancing the immune response while mitigating the “cytokine storm” that leads to morbidity and mortality in patients experiencing this syndrome.
Summary of Position
Manager, Clinical and Commercial Supply Chain will support the CMC and Clinical teams by managing and processing shipment requests for various studies, monitoring inventory for clinical studies, supporting packaging and labeling operations to generate clinical and commercial finished goods. The successful candidate works well in a fast paced, dynamic environment and will “hawk the details”.
Responsibilities
The Manager, Clinical and Commercial Supply Chain will play a leading role in translating regulatory requirements into practical, workable strategies and plans for development and commercial stage drugs.
Manage Systems and Processes to support packaging, labeling, storage and distribution of product:
For clinical studies (for example, aid in the establishment of IRT)
For commercial distribution (for example, aid in the establishment of systems for serialization of commercial product).
Work with third party providers to establish master batch records and review of executed batch records.
Responsible for processing shipment requests for drug product, drug substance and other samples:
Creating and logging requests into shipment tracking system, submitting to distributor.
Working with distributor to coordinate shipment of bulk material, including communication with Customs Brokers and international couriers.
Monitoring routine shipments (e.g. stability samples) and providing details to Customs Brokers as required.
Providing tracking information to stakeholders.
Obtaining Acknowledgements of Receipt and other information as appropriate for shipments.
Working with QA and QC to resolve temperature excursions.
Responsible for inventory control/maintenance including:
Inventory reconciliation.
Processing destruction requests.
Notification of shelf life and expiration date extensions.
Organizational support of Chemistry Manufacturing and Control Team:
Ensure documents are filed in appropriate locations (for example, executed batch records).
Routing documents for approval as required (for example, using DocuSign).
Other support activities as required.
https://www.linkedin.com/jobs/view/2660103804...fMEILMZ_2E
Pharmaceutical Clinical and Commercial Supply Chain Manager
CytoDyn United States
3 days ago 48 applicants
Apply Now
Direct message the job poster from CytoDyn
Cristina De Leon
Executive Assistant to the CEO at CytoDyn
About CytoDyn Inc.
CytoDyn Inc. (the “Company”) is a publicly traded late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on the Company’s lead drug candidate, leronlimab, a novel humanized monoclonal antibody targeting the C-C chemokine receptor type 5 (CCR5) and known as entry inhibitor to Human Immunodeficiency Virus (HIV). Leronlimab is in a class of therapeutic monoclonal antibodies designed to address unmet medical needs in the areas of HIV, cancer, and immunology. With respect to HIV, the CCR5 receptor plays a key role in the ability of HIV to enter and infect healthy T-cells. With respect to cancer and immunology, the CCR5 receptor also appears to be implicated in cancer metastasis such as triple-negative breast cancer, other metastatic solid tumor cancers, graft-vs-host disease (“GvHD”), and non-alcoholic steatohepatitis (“NASH”). More recently, the Company expanded its clinical focus with leronlimab to include evaluating its effectiveness in multiple other autoimmune indications where CCR5 antagonism has shown initial promise, as well as a therapy against COVID-19 disease and COVID-19 long hauler symptoms. The Company targets leronlimab treatment as a therapy for patients who experience respiratory complications as a result of contracting COVID-19. The Company believes leronlimab provides therapeutic benefit by enhancing the immune response while mitigating the “cytokine storm” that leads to morbidity and mortality in patients experiencing this syndrome.
Summary of Position
Manager, Clinical and Commercial Supply Chain will support the CMC and Clinical teams by managing and processing shipment requests for various studies, monitoring inventory for clinical studies, supporting packaging and labeling operations to generate clinical and commercial finished goods. The successful candidate works well in a fast paced, dynamic environment and will “hawk the details”.
Responsibilities
The Manager, Clinical and Commercial Supply Chain will play a leading role in translating regulatory requirements into practical, workable strategies and plans for development and commercial stage drugs.
Manage Systems and Processes to support packaging, labeling, storage and distribution of product:
For clinical studies (for example, aid in the establishment of IRT)
For commercial distribution (for example, aid in the establishment of systems for serialization of commercial product).
Work with third party providers to establish master batch records and review of executed batch records.
Responsible for processing shipment requests for drug product, drug substance and other samples:
Creating and logging requests into shipment tracking system, submitting to distributor.
Working with distributor to coordinate shipment of bulk material, including communication with Customs Brokers and international couriers.
Monitoring routine shipments (e.g. stability samples) and providing details to Customs Brokers as required.
Providing tracking information to stakeholders.
Obtaining Acknowledgements of Receipt and other information as appropriate for shipments.
Working with QA and QC to resolve temperature excursions.
Responsible for inventory control/maintenance including:
Inventory reconciliation.
Processing destruction requests.
Notification of shelf life and expiration date extensions.
Organizational support of Chemistry Manufacturing and Control Team:
Ensure documents are filed in appropriate locations (for example, executed batch records).
Routing documents for approval as required (for example, using DocuSign).
Other support activities as required.
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