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Senior Scientist, DMPK Bioanalytical

Req #: 17001765
Location: Summit, NJ US
Job Category: Research and Early Development
Work Location: 86 Morris Avenue CELSUM 07901
Organization: Celgene Corporation
Schedule: 40
Shift: Day Job
Employee Status: Full time
Job Type: Regular
Job Level: Manager
Travel: Yes, 15 % of the Time
Other Locations:US- NJ- Summit East

The Senior Scientist will be responsible for internal and outsourced bioanalytical activities of multiple projects, including method development, validation, and study support.  He/she will represent DMPK Bioanalytical on cross-functional study teams, and work with them to address bioanalytical-related issues.  In addition, this candidate will play a critical role as an expert in the use of advanced laboratory equipment and LIMS systems.  

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

  • Independently conduct in-house bioanalytical support for exploratory/development programs from method development, method trouble-shooting, sample analysis, data interpretation, to report preparation.  -
  • Evaluate and apply novel techniques or approaches to address challenging bioanalytical issues. -
  • Represent DMPK Bioanalytical on study teams, including the review of study protocols and providing bioanalytical strategies/deliverables. -
  • Oversee bioanalytical activities of nonclinical/clinical studies on multiple projects conducted at contract research organizations (CRO), including study sample analysis, data interpretation, report review, and timeline tracking to ensure all studies are conducted properly. -
  • Monitor all development/validation activities of bioanalytical methods conducted at CROs to ensure methods are robust, reproducible, and in compliance of all applicable regulations. -
  • Keep management apprised of project status and current scientific trends using written and oral summaries, as well as presentations. -
  • Participate in preparing Nonclinical Development Work Practices and SOPs.

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Skills/Knowledge Required: -

  • Requires PhD degree in chemistry, biochemistry, biology or related fields, and 6 or more years of relevant drug development experience within the pharmaceutical industry.  -
  • Requires in-depth expertise in bioanalytical science and a good understanding of drug development. -
  • Broad understanding of bioanalysis and its role in drug development, including method development, validation, study support, and impact of quality bioanalytical data to PK/PD correlation. -
  • Previous experience overseeing bioanalytical method development, validation, and study support performed at CRO. -
  • Strong LC/MS/MS skills with separation and quantitation (or identification) of small or large molecule therapeutics and biomarkers in biological matrices.
  • Strong foundation and experience in using, maintaining, and trouble-shooting mass spectrometers. -
  • Proven track record of performing LC/MS/MS bioanalytical method validation and study sample analysis in a GLP environment.
  • Extensive working knowledge of GLP regulations and the current bioanalytical regulatory guidance/best practices. - Good communication skills and experience in authoring and reviewing bioanalytical assay and method validation reports.  -
  • Ability to multi-task and work in a collaborative team environment.
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