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.
Location/Division Specific Information
The Clinical Next-Generation Sequencing business is part of our Life Sciences Solutions group. Personalized precision medicine has become a new paradigm in oncology treatment, offering hope for improved cancer treatments. Advances in next-generation sequencing (NGS) allow clinicians and laboratory professionals to routinely gather therapy-relevant molecular information in a timely fashion, a prerequisite for true personalized medicine in the face of a growing list of molecularly targeted drugs.
The Clinical Next-Generation Sequencing Division (CSD) offers multiple solutions for solid tumor biomarker testing to aid in identifying those patients eligible for treatment, based on Ion Torrent and Oncomine NGS technology.
How will you make an impact?
The Sr R&D Manager is responsible for leading the development of a next generation IVD sequencing system based on Ion Torrent technology. The R&D Manager leads, directs and mentors a team of R&D personnel, allocating resources as required. Will act as the technical expert and company spokesperson on new product development teams and scientific projects. The position reports to MDx R&D Director and will work closely with the MDx Product Management team and MDx Business Leader.
What will you do?
- Develop next generation IVD sequencing based assays following the Decision to Investigate through Product Commercialization Process (PCP) to Product Release Checkpoint, including involvement in clinical trial planning, site training, and data reviews for necessary regulatory submissions.
- Independently plan, direct and execute product development strategies to meet FDA (510(k) and PMA), CE-IVD, and other regulatory agency requirements. Anticipate potential problems and design preventative solutions. Determine strategic approach to experimental design.
- Critically analyze complex data, interpret and integrate experiment results with project and division objectives. Sets project directives based on data analysis. Maintain complete and thorough documentation required to meet QSR Design Control, as well as other international standards (e.g., ISO compliance, GLP/GMP requirements, etc.).
- Oversee and manage the IVD R&D staff, including hiring, performance management, training and professional development. Provide strategic direction and guidance to Scientists, Research Associates and Engineers in their daily experiments and troubleshooting. Lead team in systematic problem analysis and resolution processes for project advancement. Guide team in matrix environment.
- Interface with other departments (i.e., Marketing, Business Development, Regulatory, Technical Service and/or Operations) to coordinate product development and improvement.
- Provide guidance to MDx Product Management team and MDx Business Leader on assay product pipeline and creating technical product advantages versus competitors.
- Performs fundamental literature and patent searches related new product opportunities. Develops alternative strategies as necessary. Recognizes opportunities for in-licensing and internal patent development. Prepares patent disclosures and support the legal department in patent preparation.
- Comply with all company safety regulations and procedures. Ensure compliance of assigned staff.
- May be required to perform other related duties as required and/or assigned.
How will you get here?
Education and background:
- PhD in Biology, Chemistry, Biochemistry or related discipline, or the equivalent education and experience are required
- Minimum 6 years at Sr. Manager of R&D level in diagnostics or similar regulated industrial markets.
- Prior demonstrated success leading teams of at least 5 people.
- Proven track record in developing IVD products, with a focus on molecular assays and systems
- Experience interacting with the FDA through submissions and pre-submissions
- Experience in assessing the scientific talent of a team, re-design roles as needed, and develop and recruit scientific talent
- Demonstrated ability to collaborate with and influence colleagues on cross-functional business teams
- Track record of having had an impact on the achievement of sales and operating income objectives.
Knowledge, Skills, Abilities
- Influential communicator
- Strategic and analytical skill sets
- Knowledge of diagnostic market trends
- Persistent and flexible in response to change
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.