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Investigator II

Employer
CSL Behring
Location
Cambridge, Massachusetts
Start date
Oct 30, 2022

View more

Discipline
Regulatory, Legal/Compliance, Research/Documentation
Required Education
Masters Degree/MBA
Position Type
Contract

Job Details

Job Description

Job Summary

This position is responsible for the development and validation of clinical serological assays in support of novel vaccine candidates.  The position is responsible for testing of clinical samples and the maintenance of relevant equipment following GCLP guidance. The position is also responsible for the monitoring of clinical serological assay performed at contract testing facilities.

Major Responsibilities

The candidate will be responsible for the development and optimization of serological assays to support vaccine candidates in clinical trials. The candidate should be familiar with assay development and optimization (e.g. performing DOEs) of serological assays for both ligand binding (multiplex, e.g. Luminex) and functional assay (i.e. cell based microneutralization assays) platforms. The role may also include some collaboration on the development of relevant CMI assays. The candidate will be expected to design and perform experiments independently, perform data analysis and suggest assay optimizations based on data collected and collaboration with team.  The candidate will also need to successfully qualify and validate assays for GCLP testing.

Assist with the transfer of novel clinical assays to contract testing facilities and monitoring according to GCLP.  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. Writing of SOPs, protocols and reports (both internal and external) and comfortable preparing summary power point presentations for 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.

Minimum Requirements

  • MS or PhD in chemistry, biochemistry, molecular biology or immunology
  • MS with 10+ year or PhD with 0-3 year’s academic or pharmaceutical/biotech experience in vaccine development
  • Broad functional expertise and demonstrable scientific knowledge of ligand binding assay (including multiplexing)
  • Ability to develop and implement new assays with minimal guidance
  • Understands and recognizes the impact and implications of data
  • Working knowledge of GCLPs
  • Experience with basic data analysis (e.g. GraphPad) and presentation software
  • Strong organizational, written and oral communication skills
  • Ability to work within a matrixed team environment is essential.

About Us

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

Do work that matters at Seqirus!

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Company info
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

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