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 different 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.

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 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.

Minimum Knowledge & Experience required for the position:

• B.S 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 Cause, 5S, and RACI
• Experience in process validation, documentation and reporting
• Knowledge of ERP systems and basic cost accounting
• Strong interpersonal skills and the ability to influence senior leadership, along with all levels of the organization
• Demonstrated ability for technical proficiency, scientific creativity, problem solving skills, collaboration with other departments, and ability to manage multiple projects or assignments.
• Ability to present and communicate (oral and written) information in a clear manner.

Travel Requirements:
<10% travel requirements

Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day.  Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment.  May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch.  Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.  May occasionally have to lift and/or move up to 25 pounds.  The noise level in the work environment will vary but is usually moderate. 

Other Duties and Acknowledgement:

The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. Note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of employment with Werfen.

The salary range for this position is currently $135,000- $160,000 annually. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs.