Scientist - Assay Development (CDx) Details

Scientist - Assay Development (CDx)

Leica Biosystems - Danvers, MA

Employment Type : Full-Time

Leica Biosystems associates know that every moment matters when it comes to diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.

At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

We are looking for a Scientist to help us execute research and development activities for developing companion diagnostics (CDx) assays in support of contracted pharma projects. The Scientist will be responsible for performing required laboratory studies, making observations, preparing documents, reporting data and providing results to support key decisions within the Pharma Partnerships business unit. A proven ability to communicate and work in a complex global matrixed environment is fundamental to this role.

As a Scientist You Will . . .
Perform routine laboratory operations tasks with minimal supervision including but not limited to instrument maintenance, sample receipt and tracking, and inventory management.
Work closely with a Senior Scientist to develop and execute feasibility, development and verification studies to support the development of Companion Diagnostic Immunohistochemistry (IHC) and In Situ Hybridization (ISH) assays. Activities to be performed include, but are not limited to:
Literature searches
Study design
Reagent, study preparation
H&E, automated and/or manual biomarker staining on sectioned FFPE tissue samples
Scoring, imaging stained tissue sections
Data entry and analysis
Additional tasks as required
Work closely with a Senior Scientist to ensure deliverables are achieved in according to the project plan through appropriate scheduling of work and communication on status of assigned tasks.
Prepare study protocols, reports, and presentations. Contribute to preparation of design control documents. Ensure all work is conducted in accordance with and compliant to applicable protocols, work instructions and standard operating procedures.
Ensure all work is appropriately documented in laboratory notebooks, forms, and/or spreadsheets and follows documentation procedures.
Communicate and collaborate effectively within project team and cross-functionally within LBS and across to the wider Pharma Partnerships team.
Support and actively engage in a culture of continuous process improvement.
Employ DBS tools and processes where applicable or as assigned. Examples would include Visual Management tools, PSP tools. Etc.

To Thrive in This Role, You Will Bring . . .
BSc in a Scientific discipline required
At least 4 years of successful IVD development experience in biotech/pharma environment.
Experience with IHC and/or ISH assay development.
Awareness of requirements and experience of working competently within a regulated environment in which diagnostic assays are developed, commercialized and supported (i.e. FDA QSR, ISO 13485, etc.)
Excellent communication skills with an ability to evaluate and concisely articulate scientific issues and contribute to the implementation of solutions.
Experience in statistics and statistical analysis software is preferred.
Ability to navigate interactions across cultures, organizations and sites.
An ability to handle multiple tasks and manage priorities accordingly.

Location
This role is based in Danvers, MA

Reporting Relationship
This role reports into a Principal Scientist

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