Scientist II - Clinical Serology

CSL Behring
Cambridge, Massachusetts
Sep 19, 2020
Required Education
Masters Degree/MBA
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Job Summary :

This position is responsible for development, optimization and initial qualification of clinical serological assays to support vaccine development as well as monitoring clinical serological assay development, validation and performance at contract testing facilities

Major Accountabilities:
  • Serological assay development and optimization for viral vaccine candidates. Assay formats include antibody binding and functional assays. May include collaboration on development of CMI assays. Assay optimization for performance, data capture and analysis to support compliant high throughput testing of clinical samples. Assays may be qualified or validated prior to transfer to contract testing facilities following GLP
  • Assist with the transfer of novel clinical assays to contract testing facilities and monitoring according to GLP. Assist with monitoring assay validation and assay performance at contract testing facilities. Includes reviewing protocols, reports and some basic data analysis. Interacts with external parties
  • Documentation and presentation of scientific results. Maintains lab notebooks. Includes writing of assay protocols, preparation of internal results via reports and presentations to cross-functional teams.
  • Interact with the research group for the development of novel assays and with their deployment/transfer to a regulated clinical testing environment.
  • Reads and reviews literature to maintain awareness of new technologies and vaccine developments
  • Under general direction, contributes to the scientific development of individual clinical studies.

Minimum Requirements:
  • MS with 10+ year or PhD with 0-3 year academic or pharmaceutical/biotech experience in vaccine development
  • Broad functional expertise and demonstrable scientific knowledge of assays/techniques
  • Ability to develop and implement new assays with minimal guidance
  • Understands and recognizes the impact and implications of data
  • working knowledge of GxPs
  • experience with basic data analysis and presentation software
  • Strong organizational, written and oral communication skills and
  • Ability to work within a matrixed team environment is essential.