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 relationships
To 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.