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Principal Scientist – Bioanalysis (Biologics)

Req #: 16002023
Location: Summit, NJ US
Job Category: Research and Early Development
Work Location: Celgene Summit 86 Morris Avenue Summit 07901
Organization: Celgene Corporation
Schedule: Full-time
Shift: Day Job
Employee Status: Regular
Job Type: Standard
Job Level: Individual Contributor
Travel: No

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing we look for talented people to grow our business, advance our science and contribute to our unique culture.


Responsibilities include:


1.Development, validation and the conduct of assays to support biologics programs related to pharmacokinetics, anti-drug antibodies and neutralizing antibody assessments.  

2.Manage bioanalytical portion of Celgene non-clinical and clinical studies for biologics conducted at contract research organizations (CROs). 

3.Oversee Reagent development to support bioanalytical programs (antibodies for assays, cell lines to support NAB analysis)

4.Compile and interpret bioanalytical data, author and review protocols, reports and regulatory dossier.

5.Represent DMPK function on cross-functional biotherapeutics discovery and/or development teams.

6.Evaluate new technologies for analysis of large molecules and implement for Celgene programs.


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Qualifications
Ph.D. in biological or related sciences

Skills/Knowledge Required:

•Ph.D. in biological sciences or related discipline with >8 years experience
•Experience in method development/validation on multiple platforms for biologics
•Detailed knowledge of wide range of biologically based bioanalytical techniques including MSD, Gyros, ELISA, cell based assays and Biacore.
•Extensive PK/ADA/Nab assay problem solving and analytical skills; ability to resolve technical issues during method development, assay validation and sample analysis
•Understanding of the scientific/regulatory standards for method validation, quality control, etc with regard to the generation of bioanalytical data, use of data management & reporting software
•Proven track record of performing large molecule bioanalytical sample analysis, and performing bioanalytical method validation in a GLP environment.
•Prior experience in representing functional area in cross-functional product teams
•Proven record of peer-reviewed publications in the relevant technical areas
•Excellent interpersonal, written and oral communication skills 

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.


Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.


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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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