Manager, Biologics Procurement and Manufacturing Training - Transfusion

Introduction

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.  We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

 

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care

Overview

We are looking to hire a Biologics Procurement Manager who will manage all tasks and functions associated with Biologics Procurement and Manufacturing Training. This includes managing the supply of red blood cells and other blood products needed for Werfen's Red Cell and Capture product line. This person will also manage activities associated with training new employees and cross-training or re-training current employees as needed for Red Cell Processing, Monoclonal Production, Production Support, Controlled Components, Solid Phase, Vialing and Packaging. If you’ve got the necessary skills and experience to excel in this position, we want to hear from you. Apply today!

 

This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.

 

Manager, Biologics Procurement and Manufacturing Training

 

Responsibilities

As the Manager, Biologics Procurement and Manufacturing Training, you will be responsible for managing the process for securing the supply of red blood cells and other blood products needed for Immucor's Red Cell and Capture product line and ensuring all products meet stringent specifications. You will ensure all new hire training and cross-training or re-training for current employees are compliant within GMP/Quality. Regulatory training areas. You will assist in the design, development, and execution of manufacturing process training for manufacturing personnel. You will support corporate expectations while maintaining compliance with GMP, Quality and Regulatory guidelines for the medical device industry.  

 

Your essential duties and responsibilities include:

Ensures the continued maintenance of inventory levels for red blood cells and other blood products needed to meet production needs.

Provides direct supervision, scheduling of department staff, and manages all daily activities of the departments.

Ensure that the activities of each department are organized, timely, and completed according to department procedures or protocols. Ensure all departmental scheduling meets company requirements.

Completes timely review of department and staff records and ensures department records are legible, complete and stored according to company procedures.

Performs and documents department employee training and competency assessment in a timely manner.

Make daily decisions with regard to the operations of the Biologics Procurement and Manufacturing Training department.

Conduct interviews for new hires and provide feedback and evaluations for current staff including disciplinary actions when required.

Maintains departmental procedure manuals and completes required reviews of SOP’s and other controlled documents as required by company policy.

Maintain thorough understanding of and ensures staff adherence to all required safety standards/regulations and bio-hazardous disposal procedures in accordance with Safety and Environment regulations.

Understands GMP and ISO 13485 requirements for the manufacture of in vitro Diagnostic Devices and standards relating to large scale cell culture processes for the manufacture of IVDDs.

Ensures staff compliance with applicable company policies, procedures and regulatory requirements.

Maintains an active commitment to continuing education (attending national, state or local meetings or completing courses) not including attending in-house education functions, and independent study sessions.

Understands the source, composition, and characteristics of raw materials, components, final products and associated chemical and biosafety hazards for Red Cell and Capture Products.

Understands Biologics Procurement lab processes and equipment including req