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Position:
Sr. Scientist, Bioanalytical

Employer:
Nektar Therapeutics

Description:

The Sr. Scientist, Bioanalytical (BA) Development, is responsible for supervising the analysis of clinical (PK, ADA, biomarker) samples in support of various early and late stage studies.

Collaborates with other groups including clinical operations, clinical sample management, clinical pharmacology, and QA to ensure timely sample analysis to advance Nektar’s clinical pipeline.

  • Serving as BA Principal Investigator for clinical studies
  • Perform primary (QC) data review for the assays and results
  • Attending study team meetings as the BA representative
  • Authoring technical documents (e.g. SOPs, Memo to Files)
  • Authoring Sample Analysis Reports
  • Reviewing clinical documents supporting BA activities (e.g. lab manuals, data transfer plans)
  • Overseeing clinical sample management and analysis
  • Managing multiple direct reports
  • Ensuring compliance to FDA and EMA regulations, and Nektar SOPs
  • Recommending and implementing processes and procedures to improve quality and efficiency
  • Working with the Nektar India Bioanalytical team to align processes and procedures


Qualifications/Experience:

A PhD in a scientific discipline is required; equivalent experience may be accepted. A minimum of 5 years work experience in a research and/or development environment is required and post-doctoral work may serve as experience. 5+ years of supervisory/management experience highly desired. Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered. Must have experience in managing bioanalytical testing in a regulated GxP environment.  Must be proficient in writing technical documents and reports.  Must have excellent communication and interpersonal skills.  Experience in ligand binding assays (e.g. ELISA, ECLA). Experience with electronic notebooks and/or Watson LIMS a plus. Experience working with BA contract labs is a plus



Location: San Francisco (Mission Bay)

Contact: acandia@nektar.com

Post Date: 10/3/2019 8:56:57 AM
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