Sr. Manager Specialty Programs (REMOTE: Raleigh, North Carolina Area)

Description

Position Summary: REMOTE (Raleigh, North Carolina Area)

The individual in this position has the responsibility to manage the ADMA Bio Centers Specialty Programs in accordance with FDA requirements, guidance, and Standard Operating Procedures (SOPs). These programs must be executed in a consistent and reliable manner to achieve company goals. This position is responsible to ensure the programs are managed so that licensure of products can be achieved and maintained. These programs can be challenging and so will require communication up and down the chain of command, so all disciplines and donors are aware of scheduling and timely execution of protocols. This position, as a subject matter expert, trains and mentors’ personnel in the programs as needed. This position manages direct reports.

It is important that the person in this position understands the hours of work are determined by work requirements and task(s) which must be completed, as opposed to routine working hours.

Key Duties:

• Scheduling of activities associated with the Immunogen Cell Program and Anti-D Immunization Program.
• Coordinates with the Physician, RN, and donor to ensure immunizations can be given in accordance with protocols.
• Ensure Immunogen Cells for immunization are available for donors in accordance with protocols.
• Schedules Immunogen Cell donors for donations every eight (8) weeks. Confirms collection is executed and unit is labeled in accordance with applicable SOPs.
• Glycerolizes and deglycerolizes Immunogen Cells in accordance with applicable SOPs as needed.
• Submits microbiology sample on each lot to laboratory.
• Ensures Immunogen Cell Manufacturing Records are documented, reviewed, and maintained in accordance with applicable SOPs.
• Ensures supplies for red cell collection, manufacture, and immunization are available when needed.
• Confirms required samples for testing required for collection program have been collected and sent to correct laboratory. Monitors test submissions to confirm sample results are received.
• Submits phenotypes for potential donors to Plasma Services for Cell Assignments.
• Assists in the development, integration, and approval of new and revised SOPs.
• Creates and fosters effective lines of communication for all personnel involved in the Immunogen Cell and Anti-D Programs.
• Product Management.
• Assists in the development and maintenance of a system for inventory management.
• Prepare and submits product samples to laboratory for evaluation.
• Other Specialty Programs.
• Assists with management of RSV Program.
• As additional specialty programs are added to ADMA Bio Centers’ collection program, duties will be assigned by supervisor.
• Manages resources effectively to ensure ADMA’s goals are met.
• Maintains and performs QC on all equipment in the red cell laboratory.
• Assists in the preparation of budgets and other management plans as needed.
• Other duties as assigned by supervisor.

Qualifications

Education Requirements:

Undergraduate degree in one of the Allied Sciences (Chemistry, Biology, or Medical Technology) or professional equivalent, such as R.N. or Medical Technologist unless applicable experience equivalent is approved by senior management.

Experience Requirements: Minimum of five (5) years’ experience in a regulated environment, donor center, laboratory, drug manufacturing, medical device, or in-vitro diagnostic industry unless applicable experience equivalent is approved by senior management. Previous work experience should demonstrate expertise in interpreting cGMPs, FDA regulations, SOP development, as well as an understanding of quality principles. Previous work experience should demonstrate good interpersonal, written, and verbal communication skills, multi-tasking ability, and the ability to work independently.