Sr. Scientist, Bioanalytical (Team Manager / Project Lead)

Location
San Francisco, CA, United States
Posted
Sep 04, 2019
Ref
3615-392-2019
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

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
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

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.