Senior Manager, R&D Reagents
Senior Manager, R&D Reagents
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Salary Not Disclosed
1 Vacancy
Job Description
Overview
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.
Responsibilities
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.
Qualifications
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.
Required Experience:
Senior Manager
Employment Type
Full-Time
