Sr. Manager, Applied and Clinical Content R&D
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.
The Sr. Manager, Research & Development 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 microbial applications R&D projects and work collaboratively with product management, bioinformatics, manufacturing, and other R&D teams to take new microbial assay products and applications through concept, feasibility, development, and commercialization. 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. He/she will 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.
- Manage research and development activities through all phases of product development
- Interact cross-functionally to define products, transfer new designs to manufacturing, and ensure on-time regulatory submissions
- Identify, establish, and champion strategic technology activities
- Set clear product development timelines and prioritize efforts to deliver on commitments
- Train and teach staff in areas of expertise
- Ensure that there are adequate resources and capabilities in place to manage ongoing product development functions
- Lead R&D evaluation of new license and co-development opportunities
- Identify and facilitate academic collaborations and interactions with opinion leaders that are aligned with company goals
- Lead strategic road mapping efforts by linking potential customer requirements with R&D and product development initiatives
Required Knowledge, Skills, and Abilities
- 5+ years' experience in molecular diagnostic assay development (Could be in LDT, CE-IVD or IVD space)
- Expert in diagnostic molecular methods with expertise in technologies including qPCR, Sanger sequencing and fragment analysis.
- Familiarity with diagnostic methods for infectious diseases
- Demonstrated ability to deliver results
- Experience in a technical leadership role in diagnostics research and development
- 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, directed toward achieving objectives
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
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.