Manager, Plasma Operations

ADMA Biologics; Boca Raton, Northern (FL, KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

401K with employer match

Medical, Vision, Life & Dental

Pet Insurance

Company Paid Holidays

Paid Time Off

Tuition Assistance

Shuttle service to Tri-Rail

Job summary

ADMA Biologics in Boca Raton, Florida is seeking a Manager, Plasma Operations to lead plasma supply strategies, optimize production readiness, and supervise staff across supply chain activities. This on-site role requires 5+ years in plasma or inventory management, proficiency with SAP, and strong regulatory/compliance knowledge, with collaboration across QA and vendors.

You will maintain SOPs, coordinate shipments, lookbacks, and program testing schedules to meet manufacturing timelines and

Qualifications

• 5+ years of progressive experience in related position with in-depth knowledge of inventory management, plasma industry and manufacturing.
• Proficiency with SAP and office software packages (word processing, spreadsheets).
• Knowledge of FDA regulatory requirements and GMP basics.

Responsibilities

• Oversee plasma pool creation and preparation for IgG manufacturing.
• Manage procurement, logistics and control of human source plasma shipments.
• Ensure regulatory compliance and oversee plasma lookback processes.

Skills

Inventory management

Regulatory compliance

Vendor management

SAP

Supply chain planning

Education

Bachelor's or associate degree in business, Supply Chain or related field

Tools

SAP

Job description

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Manager, Plasma Operations in Boca Raton, Florida!

Job Title: Manager, Plasma Operations

Job Description:

Position Summary:

This is an onsite, in-person position located in Boca Raton, Florida.

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 SOP's and related documents for supply chain processes, such as plasma shipments, lookbacks, specialty programs, pool creation and plasma inventory reconciliation coordinates intermediate shipments to domestic and international customers.

Essential Functions (ES) and Responsibilities:

• Oversee and approve pool building and preparation for all IgG manufacturing. Work closely with production planning, Warehouse-Plasma Freezer Team, Mfg. 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 vs 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 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 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 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.

Job Description Footer:

In addition to competitive compensation, we offer a comprehensivebenefits package including:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet InsuranceCompany 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.