Job Details

  • Title: Scientist, Translational Development
  • Code: RCI-CELG-8284
  • Location: Cambridge Massachusetts (MA) 02142
  • Posted Date: 08/09/2019
  • Duration: 12 Months

  Job Description

Precision Medicine/CDx at Celgene:

 

Precision Medicine/CDx is part of the Global Research and Early Development organization in Celgene and leads internal and external diagnostic development activities to support multiple disease areas of interest including Myeloma, Lymphoma, MDS/AML and other hematological malignancies, inflammatory disease programs, and solid tumor indications.

 

This group will integrate scientific and business insights of multiple functions to provide innovative solutions that will make precision medicine a reality for the patients and physicians we serve. This laboratory-based position will be responsible for histological diagnostic development to support precision medicine and companion diagnostics programs across the Celgene organization.

 

Summary:

The incumbent will be based in Cambridge MA and will lead and implement development and validation of immunohistochemistry and other tissue based assays within the precision medicine and companion diagnostics organization. An ideal candidate is detail-oriented and enthusiastic about diagnostic development, thrives in a team environment, and can manage multiple projects and processes concurrently.

 

Responsibilities will include, but are not limited to, the following:

  • Develop robust, tissue-based assays to facilitate the biomarker to companion diagnostic transition
  • Generate strong datasets from analysis of tumor samples (clinical, archival) to support go/no go decisions in research/discovery target validation efforts
  • Lead and execute diagnostic assay validation for exploratory testing of clinical and commercial samples
  • Serve as a subject matter expert in Immunohistochemistry and other tissue-based assays for research and clinical teams helping to design and evaluate data from exploratory biomarker hypothesis testing and Proof of Concept studies
  • In depth knowledge and hands-on experience in immunohistochemistry procedures including: tissue dissection, routine histology, immunohistochemistry (IHC), in-situ hybridization (ISH, FISH), and image capture of fresh, frozen and paraffin-embedded tissues and cell lines
  • Establishment of experimental design, optimization, and trouble-shooting
  • Author and review controlled documents, including SOPs, validation procedures, and validation reports
  • Lead efforts to develop/obtain the best reagents and assay designs

 

Skills/Knowledge Required/Preferred:

  • BS required, advanced degree preferred in molecular biology, chemistry, biochemistry, clinical pathology or related fields and at least 5 years of professional experience working in the drug or diagnostic development area or related discipline.

 

Experience in immunology and/or oncology preferred:

  • In depth knowledge and hands-on experience in immunohistochemistry procedures including: tissue dissection, routine histology, immunohistochemistry (IHC), in-situ hybridization (ISH, FISH), and image capture of fresh, frozen and paraffin-embedded tissues and cell lines
  • Design, execute and trouble-shoot assay development experiments
  • Experience with the design, development and analysis of cellular, protein-based, and/or molecular biomarkers
  • Sound scientific understanding of key areas such as biomarkers and diagnostics
  • Strong organization and time-management skills required
  • Proven track record of scientific approach to complex problem solving
  • Strong written, oral, and presentation skills and ability to work in fast-paced team-oriented environment

 

Other Attributes:

  • Innovative spirit, thinking and desire to advance precision medicine to find solutions for our patients and increase the value proposition of our pipeline
  • Prior experience with clinical studies and diagnostic development is strongly desirable
  • Prior experience developing companion diagnostics and/or Class II or III devices strongly desirable
  • Experience with flow cytometry techniques a plus
  • Experience with Biacore analysis a plus
  • Knowledge of antigen design and antibody discovery, screening, and selection a plus
  • Experienced with method validations, good documentation practices (GDP) and good clinical practices (GCP) preferred.