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

Employer
Nektar Therapeutics
Location
San Francisco, CA, United States
Start date
Sep 4, 2019

View more

Discipline
Science/R&D, Bioanalytical Services, Biotechnology
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Bay

Job Details

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.

Company

Nektar Therapeutics is a research-based development stage biopharmaceutical company that discovers and develops innovative medicines in areas of high unmet medical need. Our R&D pipeline of new investigational drugs includes treatments for cancer and auto-immune disease. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new drug candidates. Our success is rooted in four key elements: our track record reflected by a portfolio of successful approved medicines which emanated from our chemistry platform and are made available globally by our pharmaceutical partners, our unique research and development pipeline of new investigational medicines in cancer and immunology, our proprietary and proven science and technology approach that fuels our discovery efforts and our team of dedicated scientists, clinicians and employees focused on bringing new medicines to patients with debilitating diseases.

Stock Symbol: NKTR

Stock Exchange: NASDAQ

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Company info
Website
Phone
415-482-5300
Location
455 Mission Bay Blvd South
San Francisco
California
94158
United States

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