Danaher Corporation Senior Scientist in Danvers, Massachusetts
Join Leica Biosystems as a Senior Scientist and be simulated by challenging work and inspired to learn every day! Our team develops cutting-edge diagnostic test solutions that help identify patients who are likely to benefit from our pharma partners’ emerging therapies, a critical element of personalized medicine. If you want to develop products you can feel passionate about, we want to hear from you!
This role undertakes research and development activities to support contracted pharma projects to develop companion diagnostic (CDx) IVDs, specifically in the role of R&D Lead for one (1) active pharma collaboration. The Sr Scientist provides technical and assay development direction within the CDx project team as well as acting as a liaison with external partners.
Lead active pharma collaborations and/or internal programs, specifically for the development of a tissue-based Companion Diagnostic (CDx) device
Serve as primary SME for external pharma partner.
Work closely with project management to ensure execution of project plans with an emphasis on: On Time Delivery of projects, Revenue Recognition and efficient team member utilization
Finds opportunities for activity completion, assesses risk to apply appropriate countermeasures, and partners with team with find resolution
Ensure own work and, work of all R&D team members supporting assigned project, is conducted in accordance with applicable Quality System protocols and work instructions and that all work is appropriately documented per procedure. Ensure assay development is consistent with FDA regulations and EU IVDR.
Be responsible for the Design History File as defined per the Design Control procedure including, but not limited to, the Design and Development Plan, and Development and Verification Test Plans and Reports.
Interpret results and document assay development with a high degree of complexity and scientific rigor and effectively organize documentation so that the process is traceable and understandable
Supervises technical output of project team to ensure data quality
Lead all aspects of daily activities of 1-2 Research Associates and/or Scientists; Identifies areas of strengths and development for own team members, makes recommendations for improvement and helps team members on challenges faced.
Promotes collaboration and communication between Development and line functions within Pharma Partnerships and across the company.
Support a culture of continuous process improvement and advise and participate in process improvement teams.
Lead small projects with manageable risks and resource requirements
Uses problem solving process, assessing all the alternatives in order to propose optimal solutions
BSc in a Scientific field with 6 years' industry experience OR, MS with 4 years' industry experience; or PhD with two years post-graduate experience.
IVD development experience with IHC and ISH assay development on automatic staining platforms highly desired.
Experience working with quality and regulatory requirements under which diagnostic products are developed, commercialized and supported (i.e. FDA, EU CE-IVD ) advantageous.
Experience providing guidance and mentorship within teams to drive the successful development and release of products through implementation and an ability to drive improvements.
Thrives in an environment of change and able to successfully pivot priorities or actions in response to business needs.
Check out our benefits here: https://danaherbenefitsinfo.com/
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.