Senior Manager, R&D Reagents

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.

Job Summary

The Senior Manager within R&D will lead a team of talented assay development scientists in new product development, life cycle management, and sustaining initiatives to support our Patient Blood Management (PBM) product line. The Senior Manager will play a pivotal role in advancing our diagnostic product portfolio and ensuring the highest standards of quality and performance.

Key Accountabilities

• Lead and inspire a team of scientists in the development of novel diagnostic assays from conceptualization to commercialization.
• Oversee the design, development, and process optimization for existing/on-market tests to enhance performance and reliability.
• Leverage multi-factorial analyses methods (DOE) for efficient and effective design, optimization, and robustness testing.
• Evaluate current reagent manufacturing processes and spear-head improvement initiatives.
• Experience leveraging Design for Six Sigma (DFSS) and the application of DFSS tools and principles in the product development process.
• Stay informed about advancements in diagnostic technologies and integrate relevant innovations into the assay development pipeline.
• Partner with manufacturing for reagent Design Transfer activities
• Ensure good documentation practices of results and findings for internal records and regulatory submissions.
• Collaborate with cross-functional teams, including research and development, quality assurance, regulatory affairs, and manufacturing, to ensure seamless integration of assays into IVD products.
• Work closely with external partners, collaborators, and vendors to enhance assay capabilities and stay abreast of industry advancements.
• Develop and execute project plans, ensuring adherence to timelines, budgetary constraints, and regulatory requirements.
• Collaborate with regulatory affairs to ensure compliance with relevant industry standards and regulations.
• Identify opportunities and implement continous improvement initiatives for assay development processes.
• Other duties as assigned.

Networking/Key relationshipsTo be determined based on the department needs.

Minimum Knowledge & Experience for the position:

• Advanced degree in Molecular Biology, Biochemistry, or a related field. Ph.D. preferred.
• Minimum of ten (10) years of previous experience required; medical device industry experience preferred.
• Demonstrated experience in leading assay development teams in the IVD industry.

Skills & Capabilities:

• Proven track record of successful development and launch diagnostic assays.
• Strong understanding of regulatory requirements and quality management systems in the diagnostic industry.
• Excellent leadership and interpersonal skills, with the ability to motivate and guide a multidisciplinary team.
• Proficiency in project management and resource allocation.

Travel requirements:

Travel up to 10% of the time.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com