Manager Supply Chain Plasma Operations - Adma Biomanufacturing Llc
Boca Raton, FL 33487
About the Job
IgG Manufacturing Oversight: 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.
Plasma Shipments and Logistics: 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. Conduct monthly tracking of plasma supply against forecasts to ensure sufficient plasma supply.
Plasma Lookback Process: 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.
Inventory Reconciliation: Prepare a monthly reconciliation of plasma inventory to meet Sarbanes-Oxley requirements and Inventory Controls.
Regulatory Support: Collaborate with Quality and Regulatory teams for investigations, deviations, and change control processes associated with plasma activities.
Vendor and Third-Party Management: Act as Relationship Manager, interfacing with third-party vendors and internal departments within the plasma operations process.
RSV Program Management: 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.
Supplier Contracts and Compliance: 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.
Sample Forecasting and Trend Analysis: Provide support for sample forecasting and conduct ongoing trend analysis to ensure efficiency.
Audits and Shipping Validations: 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.
Team Management: Manage the Plasma Operations team, providing oversight, training, guidance, and approving their work.
Customer Shipments Coordination: 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.
Quality Oversight for Incoming Plasma: Oversee quality for incoming plasma shipments to ensure compliance with regulations related to collection, storage, handling, and test results.
Customer Operations Team Management: Manage the Customer Operations team, reviewing and approving their work while providing guidance, training, and oversight.
Inventory and Customer Relations: Oversee and forecast supply levels at 3PL to support customer shipments. Manage customer relationships and ensure that 3PL performs order-to-cash processes as required.
Customer Complaints and Sales Support: Manage customer operations' involvement in customer complaints to ensure timely responses. Partner with the Sales team to support timely customer shipments.
Special Projects: Participate in special projects as required.
Education 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.
Experience Requirements:
A minimum of 5 years of progressive experience in a related position.
In-depth knowledge of inventory management, the plasma industry, and manufacturing processes.
Compliance Requirements:
As part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards, and SOPs.
This includes timely completion of all Quality Assurance (QA) records, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures.
Any delays or failure to comply must be escalated to the appropriate parties, including QA, HR, or EH&S.
Other Essential Knowledge:
High proficiency in office software packages, including word processing, spreadsheets, and SAP.
Must be able to work independently with strong decision-making skills.
Excellent analytical and communication skills are essential.
American Product and Inventory Control Society (APICS) certification is preferred.
Contacts:
Internal: Daily contact with administrative, management, and professional staff to exchange information, coordinate projects, solve problems, and negotiate solutions.
External: Daily contact with vendors and service providers to coordinate projects, exchange information, solve problems, and negotiate solutions.
Direct Work of Others:
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.
Working Conditions:
Sitting at a desk for more than 80% of the time, operating a PC and related software, and communicating via telephone.
Heavy workload during the end of the month.
Occasional long hours required to meet off-schedule demand, perform physical inventories, and prepare ad-hoc reports.
In addition to competitive compensation, we offer a comprehensive benefits package including:
401K 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
Fast growing company. Redesigning HR of the future for ADMA. Benefit eligible on day 30. 100% paid eye care, life insurance, STD and LTD. 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. 4% match 401k vested from day 1. Pet insurance with very low premium.
Just awarded 2023 Best Places to Work.