Plasma Operations Supply Chain Manager

3 weeks ago

Boca Raton, Florida, United States ADMA BIOMANUFACTURING LLC Full time
Job Description

ADMA Biologics is seeking a highly skilled Plasma Operations Supply Chain Manager to join our team. As a key member of our supply chain team, you will be responsible for managing plasma operations, from managing plasma shipments and overseeing inventory to facilitating the plasma lookback process across various programs.

Key Responsibilities:

  • Support plasma operations, including managing plasma shipments and overseeing inventory
  • Facilitate the plasma lookback process across various programs
  • Manage donor management, ensure proper sample testing, and maintain relationships with off-site testing labs and plasma warehouses
  • Document the entire supply chain process, including plasma shipments and inventory reconciliation, ensuring smooth operations and compliance with industry standards
  • Oversee and approve pool building and preparation for all IgG manufacturing
  • Collaborate with production planning, Warehouse-Plasma Freezer Team, Manufacturing, and QA for pool creation, approval, scheduling, and consumption
  • Responsible for supporting the procurement, logistics, and control of human source plasma shipments from approved US plasma centers to off-site storage facilities and the Boca manufacturing facility, ensuring alignment with the ADMA production schedule
  • Oversee the plasma lookback process to ensure compliance with regulatory requirements
  • Work closely with Plasma QA and Regulatory teams for plasma vendor notifications and compliance matters
  • Prepare a monthly reconciliation of plasma inventory to meet Sarbanes-Oxley requirements and Inventory Controls
  • Collaborate with Quality and Regulatory teams for investigations, deviations, and change control processes associated with plasma activities
  • Act as Relationship Manager, interfacing with third-party vendors and internal departments within the plasma operations process
  • Oversee and review donor status for the RSV Program, providing oversight for the processing, testing, and shipping of screen and titer samples to the testing lab, ensuring program requirements and testing schedules are met
  • Support the contract and approval process for plasma suppliers, including the annual Plasma Master File (PMF) review and reporting
  • Maintain and oversee procedures for all supply chain plasma operations to ensure compliance with regulations and maintain plasma supply integrity
  • Provide support for sample forecasting and conduct ongoing trend analysis to ensure efficiency
  • Travel occasionally to audit plasma centers, labs, third-party logistics (3PL)/storage facilities, and transportation suppliers
  • Participate in and support shipping validations for all lanes associated with plasma shipments
  • Manage the Plasma Operations team, providing oversight, training, guidance, and approving their work
  • Coordinate intermediate product shipments for both domestic and international customers
  • Collaborate with Compliance, Manufacturing, Warehouse, QC, and QA teams to arrange shipments and process sales orders, maintaining customer-specific requirements for each shipment
  • Oversee quality for incoming plasma shipments to ensure compliance with regulations related to collection, storage, handling, and test results

Requirements:

  • Bachelor's or Associate degree in business, supply chain, or a related field
  • Alternatively, at least 5 years of experience in a highly automated inventory system environment, preferably in manufacturing or the plasma industry
  • In-depth knowledge of inventory management, the plasma industry, and manufacturing processes
  • High proficiency in office software packages, including word processing, spreadsheets, and SAP
  • American Product and Inventory Control Society (APICS) certification is preferred

Working Conditions:

  • Daily contact with administrative, management, and professional staff to exchange information, coordinate projects, solve problems, and negotiate solutions
  • Daily contact with vendors and service providers to coordinate projects, exchange information, solve problems, and negotiate solutions
  • Manage relationships with plasma vendors, plasma centers, contract manufacturing organizations, logistics service providers, and inventory management
  • Coordinate inventory management and plasma requirements with other departments to meet production schedules

Benefits:

  • 401K plan with employer match and immediate vesting
  • Medical, Vision, Life and Dental Insurance
  • Company Paid Holidays
  • Easily accessible to Tri-Rail
  • Free Shuttle to the Boca Tri-Rail station
  • 75% employer paid medical with low premiums
  • PTO of 12 per year for first two years and then goes up from there, holidays, three floating holidays

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