Project Manager – Chemistry, Manufacturing and C
Post# of 155585
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Posted On: 10/08/2024 1:41:23 PM
Project Manager – Chemistry, Manufacturing and Control
CytoDyn Inc.
Position: Project Manager – Chemistry, Manufacturing and Control
Reports to: VP - Operations
Location: Remote
About CytoDyn Inc.
CytoDyn Inc. (the “Company”) is a publicly traded 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 inflammation.
Summary of Position
The CMC Project Manager will support the VP – Operations by supporting the clinical supply chain, the Document Control function, regulatory submissions for documents such as annual reports. The successful candidate works well in a fast paced, dynamic environment and will “hawk the details”.
Responsibilities
The Project Manager, CMC, will play a leading role in:
Management of Systems and Processes to support packaging, labeling, storage and distribution of product:
For clinical studies (for example, aid in the establishment of IRT)
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 items:
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.
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:
Summarizing stability study data in data tables
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.
Support Document Control Function
Management of review of SOPs and other controlled Documents
Support Quality Logs for items such as CAPA, Change Control
Work Style
You are highly organized.
You can work within an environment with multiple priorities.
You are self-sufficient and know when to ask questions.
You're willing to help wherever needed.
You take ownership and pride of your work.
You are a learner with a mindset centered around continuous improvement.
You strive to do what it takes to ensure the job is done right the first time.
You have the ability to function effectively, prioritize, and execute in a fast-paced, dynamic environment.
You have a “Quality” mind-set.
Qualifications
S./B.A. in life science, business operations, supply chain management or related fields.
At least 3 years’ experience in the pharmaceutical industry within clinical development
Excellent communication skills, both verbal and written.
Must be detail oriented and have solid problem solving and organizational skills.
Position requires compliance with standard operating procedures and international industry regulations.
Working knowledge of Microsoft Office applications, particularly Microsoft Excel, Word and PowerPoint.
Must be customer-service oriented.
Experience with ex-US studies is a plus.
Experience working in an ERP system is a plus.
Individual must be comfortable working in a remote environment.
Benefits
Competitive salary, stock option compensation, PTO, and Company holidays.
100% company paid medical/dental benefits for employees and all dependents.
401(K) Plan eligibility including employer “safe harbor” contribution equal to 3% of salary regardless of employee contribution.
Flexible Spending Account (“FSA”) allowing employees to set aside pre-tax wages for medical costs.
Please send your cover letter and resumé to: careers@cytodyn.com
© 2024 CytoDyn Inc. All Rights Reserved.
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CytoDyn Inc.
Position: Project Manager – Chemistry, Manufacturing and Control
Reports to: VP - Operations
Location: Remote
About CytoDyn Inc.
CytoDyn Inc. (the “Company”) is a publicly traded 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 inflammation.
Summary of Position
The CMC Project Manager will support the VP – Operations by supporting the clinical supply chain, the Document Control function, regulatory submissions for documents such as annual reports. The successful candidate works well in a fast paced, dynamic environment and will “hawk the details”.
Responsibilities
The Project Manager, CMC, will play a leading role in:
Management of Systems and Processes to support packaging, labeling, storage and distribution of product:
For clinical studies (for example, aid in the establishment of IRT)
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 items:
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.
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:
Summarizing stability study data in data tables
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.
Support Document Control Function
Management of review of SOPs and other controlled Documents
Support Quality Logs for items such as CAPA, Change Control
Work Style
You are highly organized.
You can work within an environment with multiple priorities.
You are self-sufficient and know when to ask questions.
You're willing to help wherever needed.
You take ownership and pride of your work.
You are a learner with a mindset centered around continuous improvement.
You strive to do what it takes to ensure the job is done right the first time.
You have the ability to function effectively, prioritize, and execute in a fast-paced, dynamic environment.
You have a “Quality” mind-set.
Qualifications
S./B.A. in life science, business operations, supply chain management or related fields.
At least 3 years’ experience in the pharmaceutical industry within clinical development
Excellent communication skills, both verbal and written.
Must be detail oriented and have solid problem solving and organizational skills.
Position requires compliance with standard operating procedures and international industry regulations.
Working knowledge of Microsoft Office applications, particularly Microsoft Excel, Word and PowerPoint.
Must be customer-service oriented.
Experience with ex-US studies is a plus.
Experience working in an ERP system is a plus.
Individual must be comfortable working in a remote environment.
Benefits
Competitive salary, stock option compensation, PTO, and Company holidays.
100% company paid medical/dental benefits for employees and all dependents.
401(K) Plan eligibility including employer “safe harbor” contribution equal to 3% of salary regardless of employee contribution.
Flexible Spending Account (“FSA”) allowing employees to set aside pre-tax wages for medical costs.
Please send your cover letter and resumé to: careers@cytodyn.com
© 2024 CytoDyn Inc. All Rights Reserved.
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