Director, Operations, Warren, NJ

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.

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

Director, Operations

Responsible for manufacturing operations for the Warren site. Provides day to day leadership and management of production, manufacturing improvements, and execution of sitewide operational excellence initiatives. Works to improve quality and ensure products ship on time. Site champion of Werfen Values, exemplifying a culture of teamwork and collaboration. Also responsible for new product transfer from R&D, including process design and process transfer. Partners with Quality counterpart to ensure both site and customer quality goals are met.

Responsible for the on-time production of BeadChip and NGS products, including IVD, CE and RUO markets globally
• Prior production experiences with processing of silicon wafers and nano-manipulator of chips with biological functionalities is preferred.
• Monitor Absorption metrics regularly to ensure timely and cost-effective production.
• Responsible for all employees within Operations
  • Promotes Werfen Values and collaboration within and across departments.
  • Ensure training and competency of production personnel.
  • Promotes continuous improvement mindset.
• Participate in new products transfers.
• Manage and maintain site production areas
  • Participate in design of new production equipment and validation studies.
  • Timely completion and installation of qualified CAPEX equipment.
• Participate in timely completion of investigation on non-conforming issue.
• Provide briefings, reports, and trending analysis to document site progress.
• Performs other duties and responsibilities as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions

Networking/Key relationships

• Develops a strong working relationsip with Quality counterpart, ensuring high quality products are being built.
• Works with Supply Chain partner to ensure inventory levels are appropriate while maintaining necessary materials and components to manufacture products on time.
• Defines the overall plan for site's success with Senior Director, Operations.

Minimum knowlege & Experience Requirements

• Education: Bachelor's degree (BS/BA) from four-year college or university; or equivalent combination of education and experience.
• Experience: Minimum of 8-10 years of manufacturing experience in the medical device field or similar regulated environment.
• Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Collaborative leader with a focus on developing and coaching team members and promoting a team-first mentality.
• Strong business acumen and organizational development skills.
• Strategic thinking, problem-solving, and organizational leadership.
• Excellent communication skills with executive presence.
• Energetic, forward-thinking, and creative with high ethical standards.
• Experienced in resolving conflicts and driving change.
• Passion for customer and patient focus.

Travel requirements: Occasional travel to conferences and operatios meeting