Viking Therapeutics, Inc.
Manager, Clinical Supply Chain
Viking Therapeutics, Inc., San Diego, California, United States, 92189
Manager, Clinical Supply Chain
– Viking Therapeutics, Inc.
We are looking for an experienced and professional Manager of Clinical Supply Chain who will be responsible for managing the GMP inventory and global logistics at Viking’s San Diego site.
The Manager will report to the Director of Clinical Supply Chain and will work cross‑functionally with Quality Control, Quality Assurance, CMC, the development team, regulatory, and external vendors.
The role will define and operationalize the clinical supply chain system, support clinical material manufacturing globally, and determine distribution strategy for the lifecycle of products from pre‑IND through post‑launch.
Essential Duties and Responsibilities
With minimal supervision, manage and support investigational drug product supply and logistics activities, including demand forecasting, supply planning, IRT start‑up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, returns, reconciliation, destruction, cold chain management, and inventory management.
Monitor inventory levels to ensure no shortage of investigational material product throughout the life of a clinical trial.
Manage packaging and labeling/distribution vendors, including relationship management.
Prepare clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, and destruction certification, coordinating the origination, proofing, and translation of study labels.
Proactively identify potential issues and develop mitigating actions.
Interpret clinical study protocols to create clinical material demand forecasts.
Attend clinical study and cross‑functional meetings as needed.
Oversee execution of multiple clinical trials and proactively identify potential supply chain issues and recommend solutions to global supply chain.
Manage clinical study close‑out activities, including returned goods, reconciliation, and inventory destruction.
Support drug supply delivery through coordination of CMC efforts (including CMC, Clinical Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations).
Support temperature excursion processes as required.
Support IRT system development and lead development of user requirement specifications and management modules as applicable.
Perform other duties as assigned.
Requirements
Bachelor’s degree in Chemistry, Pharmacy, or a relevant discipline.
6+ years of industry experience in supply chain operations.
Significant experience with global shipping and logistics of materials.
Experience working in an FDA‑regulated environment.
Experience with establishment and maintenance of GMP quality‑controlled storage.
Direct experience with importing/exporting documentation (permits, licenses, declaration letters) for global distribution of live virus banks, cell banks, and raw materials.
Direct experience with third‑party vendors for shipping/logistics services.
Knowledge of cGxP and regulatory compliance requirements in the pharmaceutical industry.
Experience reviewing and authoring SOPs related to CMC clinical supply chain.
Experience in GMP warehouse inventory management, specifically in biotech/pharma.
Experience with inventory management systems a plus.
Technical working knowledge of product packaging or design a plus.
Comfortable in a fast‑paced, dynamic, and highly fluid company environment with minimal direction.
Strong computer skills with Microsoft Office and ability to quickly learn new applications.
Team player with strong communication, interpersonal skills and ability to build effective working relationships at all levels.
EEO Statement Viking Therapeutics, Inc., is committed to equal opportunity in employment for all employees and applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, disability, or veteran status. Viking adheres to all applicable nondiscrimination laws and to requirements for work authorization and immigration compliance.
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– Viking Therapeutics, Inc.
We are looking for an experienced and professional Manager of Clinical Supply Chain who will be responsible for managing the GMP inventory and global logistics at Viking’s San Diego site.
The Manager will report to the Director of Clinical Supply Chain and will work cross‑functionally with Quality Control, Quality Assurance, CMC, the development team, regulatory, and external vendors.
The role will define and operationalize the clinical supply chain system, support clinical material manufacturing globally, and determine distribution strategy for the lifecycle of products from pre‑IND through post‑launch.
Essential Duties and Responsibilities
With minimal supervision, manage and support investigational drug product supply and logistics activities, including demand forecasting, supply planning, IRT start‑up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, returns, reconciliation, destruction, cold chain management, and inventory management.
Monitor inventory levels to ensure no shortage of investigational material product throughout the life of a clinical trial.
Manage packaging and labeling/distribution vendors, including relationship management.
Prepare clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, and destruction certification, coordinating the origination, proofing, and translation of study labels.
Proactively identify potential issues and develop mitigating actions.
Interpret clinical study protocols to create clinical material demand forecasts.
Attend clinical study and cross‑functional meetings as needed.
Oversee execution of multiple clinical trials and proactively identify potential supply chain issues and recommend solutions to global supply chain.
Manage clinical study close‑out activities, including returned goods, reconciliation, and inventory destruction.
Support drug supply delivery through coordination of CMC efforts (including CMC, Clinical Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations).
Support temperature excursion processes as required.
Support IRT system development and lead development of user requirement specifications and management modules as applicable.
Perform other duties as assigned.
Requirements
Bachelor’s degree in Chemistry, Pharmacy, or a relevant discipline.
6+ years of industry experience in supply chain operations.
Significant experience with global shipping and logistics of materials.
Experience working in an FDA‑regulated environment.
Experience with establishment and maintenance of GMP quality‑controlled storage.
Direct experience with importing/exporting documentation (permits, licenses, declaration letters) for global distribution of live virus banks, cell banks, and raw materials.
Direct experience with third‑party vendors for shipping/logistics services.
Knowledge of cGxP and regulatory compliance requirements in the pharmaceutical industry.
Experience reviewing and authoring SOPs related to CMC clinical supply chain.
Experience in GMP warehouse inventory management, specifically in biotech/pharma.
Experience with inventory management systems a plus.
Technical working knowledge of product packaging or design a plus.
Comfortable in a fast‑paced, dynamic, and highly fluid company environment with minimal direction.
Strong computer skills with Microsoft Office and ability to quickly learn new applications.
Team player with strong communication, interpersonal skills and ability to build effective working relationships at all levels.
EEO Statement Viking Therapeutics, Inc., is committed to equal opportunity in employment for all employees and applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, disability, or veteran status. Viking adheres to all applicable nondiscrimination laws and to requirements for work authorization and immigration compliance.
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