Manager, Plasma Operations

ADMA BioCenters; Boca Raton (FL); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

401(k) plan with employer match and immediate vesting

Medical, vision, life and dental insurance

Pet insurance

Company paid STD and LTD

Paid holidays

3 weeks’ paid time off

Tuition assistance

Free shuttle to the Boca Tri-Rail station

Job summary

ADMA BioCenters in Boca Raton, Florida is seeking a Manager, Plasma Operations to oversee plasma supply strategies, ensuring regulatory compliance and operational efficiency. This role requires managing all aspects of plasma operations, including supervising staff and coordinating plasma shipments.

The successful candidate will have a Bachelor’s degree and at least 5 years of relevant experience in inventory management and the plasma industry. The position also offers comprehensive benefits, including medical and dental insurance, 401(k) plan, and paid time off.

Qualifications

• Minimum of 5 years of progressive experience in a related position.
• High proficiency in office software packages, including word processing and spreadsheets.
• In-depth knowledge of inventory management and plasma manufacturing.

Responsibilities

• Oversee and approve pool building and preparation for IgG manufacturing.
• Support procurement, logistics, and control of human source plasma shipments.
• Review and approve monthly reconciliation of soft goods and plasma inventory.
• Ensure adherence to regulatory requirements for plasma lookback process.
• Manage relationships with third-party vendors and departments.

Skills

Inventory management

Regulatory compliance

Office software proficiency

Plasma industry knowledge

Quality assurance

Education

Bachelor’s or associate degree in business, supply chain or related field

Tools

SAP software

Job description

Manager, Plasma Operations – Boca Raton, Florida

Position Summary

The Manager, Plasma Operations manages plasma supply strategies to support operations and maximize process efficiency and productivity. Oversees and supports all Plasma Operations activities, supervises staff, creates and maintains SOPs and related documents for supply chain processes such as plasma shipments, lookbacks, specialty programs, pool creation and plasma inventory reconciliation, and coordinates intermediate shipments to domestic and international customers.

Essential Functions and Responsibilities

• Oversee and approve pool building and preparation for all IgG manufacturing. Work closely 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 approved off‑site storage facilities through to the Boca manufacturing facility to meet the ADMA production schedule. Monthly tracking of plasma supply versus forecast to ensure adequate plasma supply.
• Oversee the plasma lookback process to ensure adherence to regulatory requirements. Works closely with Plasma QA and Regulatory for plasma vendor notifications and compliance.
• Review and approve monthly reconciliation of soft goods and plasma inventory for Sarbanes Oxley requirements and Inventory Controls.
• Work with Quality and Regulatory for investigations, deviations, and the change control processes associated with plasma activities.
• Relationship Manager for interfaces with third‑party vendors and departments within the plasma operations processes.
• Oversee and review donor status for the RSV Program by providing oversight of the processing, testing and shipping of screen and titer samples to the testing lab to meet program requirements and testing schedules.
• Partner with plasma suppliers to ensure specialty programs are managed efficiently.
• Support contract and approval process for plasma suppliers including annual Plasma Master File (PMF) review and reporting.
• Maintain and oversee procedures for all supply chain plasma operations to ensure all regulations are met and the plasma supply is maintained in a state of compliance.

Education & Experience Requirements

Education Requirements

• Bachelor’s or associate degree in business, supply chain or related field.

Experience Requirements

• Minimum of 5 years of progressive experience in a related position with in‑depth knowledge of inventory management, plasma industry and manufacturing.
• High proficiency in office software packages, including word processing, spreadsheets, and SAP required.

Preferred Experience

• Minimum of 5 years of progressive experience in a related position with in‑depth knowledge of inventory management, plasma industry and manufacturing.

Compliance Requirements

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Benefits

• 401(k) plan with employer match and immediate vesting
• Medical, vision, life and dental insurance
• Pet insurance
• Company paid STD and LTD
• Company paid holidays
• 3 weeks’ paid time off (within the first year)
• Tuition assistance (after the first year)
• Easily accessible to Tri‑Rail
• Free shuttle to the Boca Tri‑Rail station

ADMA Biologics uses E‑Verify to confirm the employment eligibility of all newly hired employees. To learn more about E‑Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employer.