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Sr. Manager, IVD Process Development - Clinical Vertical R&D

Organization
Thermo Fisher Scientific
Job Location
-
Austin, TX 78701
United States
Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

How will you make an impact?

The Sr. Manager, IVD Process Development - Clinical Vertical R&D will have leadership responsibility in planning and oversight for scientific activities in the research and development of in clinically oriented products. Housed within the Genetic Sciences Division of Thermo Fisher Scientific, the successful candidate will lead regulated product development for infectious diseases and work collaboratively with product management, bioinformatics, manufacturing, and other R&D teams to take new assay products and applications through concept, feasibility, development, and commercialization.

What will you do?

• Manage a team of R&D scientists through all phases of product development with the design, development and validation of integrated automated systems under ISO13485
• Demonstrate expertise with automated liquid handlers including programming/scripting and strong proficiency with method development including sample prep and assay integration on liquid handlers for the implementation of infectious disease workflows
• Build a team of assay integration scientists that coordinate with technical leader on concept to development transfer; works with tech leader and systems team to characterize automation dependencies and tolerances
• Interact cross-functionally to define products, transfer new designs to manufacturing, and ensure on-time regulatory submissions
• Train and grow automation scientists in process and method development, troubleshooting, commercial launch, and customer support
• Ensure that there are adequate resources and capabilities in place to manage ongoing product development functions
• Work across different sites and teams globally to deliver products

Experience with developing product with IVD and/or CE-IVD is critical. In addition, the candidate will actively participate in external communication and collaborations with thought leaders in microbiome and infectious disease research & diagnostics. The person will also lead a team of scientists and be responsible for setting their short and long-term goals and career planning. This position will be responsible for developing and setting near-term and long-term research and development objectives. Ensure that R&D staff pursues the highest level of technical competency and professionalism in all development activities and that all projects are aligned to the needs of the customers and business, and that developmental timelines are met. In this position, you will drive results through inspired leadership and a focused and disciplined approach to product development that is consistent with best practices in the Company and in the industry as well as in compliance with appropriate regulatory requirements. This position will act as a resident expert for assays in development and deploying automated protocols for the Clinical Vertical.


How will you get here?
Education/Experience:

• Ph.D. with 5+ years or Master with 10+ years along with industry experience required
• 5+ years’ experience in molecular diagnostic assay development (CE-IVD or US IVD space)
• Expert in process and method development on automation platform(s) including the Hamilton systems and expertise in technologies including qPCR analysis
• Expertise in sample prep and diagnostic methods for infectious diseases
• Experience in a technical leadership role in diagnostics research and development
• Ability to travel and work in a highly matrixed, fast-paced organization

Knowledge, Skills, Abilities:

• Demonstrated ability to deliver results
• Must be capable of evaluating the potential of new technologies and their value to the marketplace
• Market-focused with the ability to anticipate changes in needs and potential problems
• Demonstrated ability to build and foster relationships with scientific and medical thought leaders.
• Familiarity with the process of obtaining CE-IVD and/or FDA clearance/approval of In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics
• Understanding of Quality Systems Regulations and cGMP product development
• Driven to deliver quality results on time and in a highly ethical and professional manner
• Strong leadership and people management skills, including recruiting, motivating, and organizing a disciplined R&D team
• Demonstrated resourcefulness, strategic and analytical thinking, and directed toward achieving objectives

 

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

 

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.