Supply Chain Manager

Integrated Resources, Inc ( IRI ); United States; Remote; USD 105,000 - 125,000; Full time

Job summary

A leading company in the biotechnology sector is seeking a Clinical Supply Manager to oversee clinical supply activities and manage drug product inventory. The ideal candidate will have a B.S. in a related field and significant experience in global clinical supply chain management. This remote position offers a contract duration of 12 months and requires collaboration with various teams to ensure compliance and efficiency in clinical supply operations.

Qualifications

• 4+ years of global clinical supply chain experience in biotechnology.
• Experience in managing clinical supply chains and regulatory inspections.

Responsibilities

• Oversee clinical supply activities and manage drug product inventory.
• Collaborate with cross-functional teams to ensure optimal execution of strategies.

Skills

Attention to Detail

Communication

Planning

Collaboration

Inventory Management

Education

B.S. in a scientific, healthcare, or related field

Tools

MS Office

Job description

Direct message the job poster from Integrated Resources, Inc ( IRI )

Lead Recruiter at Integrated Resources Inc. (IRI)

Clinical Supply Manager

Location : Remote

Duration -12 months

Shift Timing- EST Hours

Education:

• B.S. in a scientific, healthcare, or related field with 4+ years of global clinical supply chain experience within the biotechnology sector. APICS certification is advantageous.
• Proven history of establishing, refining, and managing clinical supply chains within the biotechnology industry.
• Solid understanding of GMPs, GCPs, GDPs (GxP) requirements
• Strong attention to detail with excellent follow-up.
• Progressive knowledge of Import/export regulations, including pro-forma invoice generation, import regulations, and global trade compliance.
• Previous successful collaboration & management of third-party CRO’s and CMO clinical supply operations.
• Strong experience of GxP & Systems including development of specifications, oversight of system operations, troubleshooting & identifying gaps, performing set-up & testing of systems, & understanding areas of limitations, risks, or gaps to mitigate. (IRT).
• Exceptional written and verbal communication, with diligence, collaboration, ability to manage complex challenges, and influencing skills.
• Excellent planning, organizational skills, and the ability to work simultaneously on multiple projects with tight timelines.
• Experienced in assisting, as the Clinical Supply Chain SME, during Regulatory Inspections and Audits.
• Proactive in driving performance cross-functionally and fostering collaboration.
• Ability to build/drive internal team consensus.
• Translates broad strategies into specific objectives and action plans.
• Proficient knowledge of MS Office (Smartsheet, Excel, PowerPoint, Visio, Project, etc.)

Certifications & Licenses:

• APICS certification
• CMC
• CSC

Skills:

• Oversee clinical supply activities, encompassing label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management.
• Facilitate timely startup of new studies through prompt supply availability.
• Manage the Clinical Supply program for investigation drug product inventory management and distribution in partnership with CMOs; evaluates drug utilization versus forecast considering country requirements and logistical timelines.
• Responsible for the oversight of Clinical Supply CMOs.
• Responsible for the management of global strategies in IRT systems.
• Responsible for the creation, periodic review, and maintenance of all Clinical Supply SOPs.
• Accountable for initiating, overseeing, and resolving departmental deviations.
• Collaborate with cross-functional teams (Clinical Operations, QA, CMC, and Regulatory) to ensure optimal execution of Clinical Supply strategy and identify and address potential risks to the progression of clinical programs proactively.
• Function as the internal point person for addressing product issues, temperature excursions, and deviations originating from clinical sites or depots. Collaborate with Quality Assurance to address any quality-related matters.
• Serves as the primary representative/subject matter expert (SME) during all inspections and clinical supply chain audits.
• Serve as a subject matter expert and devise continuous improvement plans for clinical supply GMP, GDP, and business processes.
• Assist in ongoing drug accountability and reconcile end-of-study drug inventory.
• Provide clinical supply and risk mitigation recommendations.
• Oversee inventory management of study drug and comparators at depots.
• Mentor CSC team members as needed on programs and systems.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Supply Chain

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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