Sr Supply Chain Manager

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Job details

Nationally recognized biopharmaceutical company, innovating medicines for the treatment of cancer and autoimmune diseases is seeking a Sr Supply Chain Manager for a Direct Hire/ Remote position on their team

This Jobot Job is hosted by Doug Cottengim

Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.

Salary $125,000 - $165,000 per year

A Bit About Us

Nationally recognized biopharmaceutical company, innovating medicines for the treatment of cancer and autoimmune diseases is seeking a Sr Supply Chain Manager for a Direct Hire/ Remote position on their team. The Manager, Clinical Supply Chain will be responsible for managing drug product manufacturing for several clinical studies/programs in various phases at CMO/CDMO. Manager will demonstrate leadership ability, end-to-end clinical supply chain expertise (managing all aspects of clinical supplies in a global trial setting).

Responsibilities

• Maintain appropriate documentation in compliance with domestic and international regulations.
• Review and approve documentation related to packaging, labeling, and distribution of clinical trial materials.
• Manage clinical trial materials distribution and logistics for global clinical programs, including importing and exporting clinical supplies.
• Work with the clinical team to configure and set up Interactive Response Technology (IRT) Systems including automated randomization and drug supply management, including specification design & UAT testing.
• Strategically manage procurement, packaging, labeling, distribution, returns, reconciliation, destruction and storage tasks for all clinical trial materials (including medical devices and/or ancillary as required).
• Work collaboratively with Clinical Operations, CRO, Quality Assurance, CMO, and Regulatory Affairs to develop supply strategy to maximize supply efficiency, minimize waste, and develop risk mitigation plans to proactively identify any potential issues that may impact drug supply.
• Manage all clinical supply activities for on-time delivery, which includes demand forecasting, trial monitoring & resupply planning, packaging/distribution, Interactive Response Technology (IRT) set-up and distribution activities.
• Review clinical protocols and translate clinical study requirements into demand for clinical trial materials (including medical devices and/or ancillaries as required) for supporting multiple global clinical studies.

Why join us?

Benefits

401(k)

401(k) matching

Dental insurance

Flexible schedule

Health insurance

Health savings account

Paid time off

Professional development assistance

Referral program

Job Details

Qualifications

• Detailed understanding of regulatory requirements for clinical supply distribution in US, APAC, LATAM, and EU including testing and labeling requirements.
• Requires a BS degree with a minimum of 5 years’ experience in a clinical supply chain management role in a biopharmaceutical industry.
• Global distribution experience including working with QP, IXRS and regional depots.
• Detailed understanding of regulatory and Good Manufacturing Practices and Good Distribution Practices requirements for IMP supply and national/international transportation requirements for pharmaceutical materials.
• Manage vendor oversight activities and vendor performance to ensure high quality, cost effective execution of outsourced clinical supply activities.
• Experience managing contract packaging and labeling organizations (strongly preferred).
• Experience with developing risk-based Clinical Trial Supplies management from early to late phases international clinical studies (double-blind, comparator).

Interested in hearing more? Easy Apply now by clicking the "Apply" button.

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