Manager OR Senior Manager, R&D Product Transfer - AID

Introduction Werfen 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 Job Summary This position is responsible for product development and design transfer activities for new products from R&D to Manufacturing. The position requires utilization of both technical knowledge and lean concepts to manage the overall new product introduction activities ensuring that the resulting finished products meet all required safety, quality, and manufacturability by a process of robust design control that includes both product/process development and process validation activities. As Product Transfer & Packaging Design Manager, this position is responsible of managing the department, leading the transfer of new products coming from R&D or an external party to the diferent operations areas. Post launch, the department addresses performance issues and improvements throughout the product life cycle. The R&D Product Transfer group’s mission is to enable seamless transitions for new products (assays) to manufacturing by creating all the necessary specifications, processes, procedures and structures for a product to meet/exceed the intended use and product performance claims. Responsibilities Key Accountabilities Manage the R&D Product Transfer department. Coordinates and directs all new Product Development and Transfer activities. Areas of responsibility include ensuring execution of process development and validation studies including development and implementation of appropriate raw material specifications, analytical test methods and QC release test methods through Design Control to successful launch. Leads the activities and resources associated with the product transfer process and associated design control requirements. Ensures that RA and QA requirements are met in accordance with FDA and ISO guidelines for design control that meet product performance requirements and are reproducible and QSR/ISO compliant. Understands IVDR requirements. Use statistical and risk management techniques to product development and design manufacturing process flow. Responsible for the coordinating with Value Stream Leaders to ensure product transfer complies with standard operating practices. Ensure that the group leaders have all resources (tools, training, information) in order to ensure all activities are implemented at the right time To follow up all the activities involved in the industrialization process from R&D, Technical Support or an external company to Manufacturing To drive excellence in manufacturing processes, efficiency, productivity, meeting all the quality and regulatory requirements to better serve our internal customers. Troubleshoot product complaints and non-conformances. Lead CAPA investigations and corrective actions pertaining to assay specifications and performance issues. Networking/Key Relationships The Product Transfer Manager/ Sr. Manager is the key contact person for the entrance of new products into the Werfen manufacturing site. Collaborate and share Best Practices within the R&D organization: Feasibility, Verification & Validation, On Market Support and Scientific Affairs. Act as liaison between Operations and R&D. Facilitating dialogue, collaboration and the exchange of information between: Project Management, R&D, On Market Support, purchasing, manufacturing, planning, labeling and filling & packaging sections, quality assurance and quality control. Partner with RA/QA to ensure product Validation meets requirements for new product introduction and product changes/improvements. Partner with HR to create development plans for employees. Qualifications Minimum Knowledge & Experience required for the Senior Manager position: PhD or M.S in Chemistry or related field Experience: 10+ years of progressive management and leadership experience, preferably In-Vitro Diagnostics or autoimmunity. Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR, IVD-R and ISO 13485. 8+ years of conducting investigations strongly preferred Minimum Knowledge & Experience required for the Manager position: BS or PhD in Chemistry or related field Experience: 8+ years of progressive management and leadership experience, preferably In-Vitro Diagnostics or autoimmunity. Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR, IVD-R and ISO 13485. 5+ years of conducting investigations strongly preferred Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities Immunoassay experience (Bead-based or Luminex technology strong plus). Strong knowledge in Design Control elements and considerable experience with Product Development and Design Transfer activities. Experience in use of statistical programs including DOE Strong project management skills Lean Six Sigma advocate with experience in: Value-Stream Mapping, DMAIC, Fishbone Diagram, Kanban, Process Mapping, FMEA, Root