Jobs
View more job listings or post a job
Revolution Medicines Senior Scientist, DMPK and Clinical Pharmacology
Quintara Discovery Research Scientist (Bioanalysis)
Quintara Discovery Research Scientist (Bioanalysis)
Chinook Therapeutics, Inc Sr. Scientist, In Vivo Pharmacology (Team Lead)
AbVision Senior/Principle Scientist (Immunology/Cell Biology)
Genentech, Inc. Associate Scientist, Biomarker Mass Spectrometry Laboratory  
Genentech, Inc. Senior Scientific Researcher for Biomarker Mass Spectrometry Laboratory
Genentech Inc. Contractor Scientist–Drug Metabolism
Genentech, Inc. Associate Scientist / Scientist, Biotransformation and ADME of New Modality  
Genentech, Inc. Scientist / Sr. Scientist, Drug Metabolism and Pharmacokinetics  
Post a job


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
┬ęPharmaceutical & BioScience Society, International; Last Modified: 7/9/2020; Admin Logon
Ads (in random order)
Submit a Text Ad
($250 for 2 months)

Alturas Analytics, Inc. Expert GLP & non-GLP LC-MS/MS, GC-MS/MS bioanalytical & PK/TK analysis services of small & large molecules in any matrix. Discovery through phase IV.
Hypha Discovery Ltd. Experts in scalable synthesis & purification of drug metabolites, including CYP, AOX, FMO metabolites as well as O-, N-, acyl glucuronides & sulfates.
Submit a Text Ad