Scientist, Biologics (Stability)
- Employer
- Nektar Therapeutics
- Location
- San Francisco, CA, United States
- Start date
- Sep 4, 2019
View more
- Discipline
- Science/R&D, Biotechnology
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
As part of Nektar's Biologics CMC organization, the Scientist, Biologics (Stability) will support early and late stage development of biologic drug candidates.
The Scientist, Biologics (Stability) must have knowledge and hands-on experience with the design and set up of GMP stability studies and analytical testing of biologics (HPLC, SEC, CE and IEX). Experience with CRO management and CMC regulatory documents is a plus. The Scientist, Biologics (Stability) will be responsible for performing a variety of activities to support GMP stability study and stability testing for Biologics programs including:
- Author/review stability protocols and coordinate with CMOs to set up stability studies in compliance with ICH guidelines and FDA/EMEA regulations.
- Coordinate stability sample pulls and distribution of samples stored at third party facility.
- Manage/Execute in-house stability testing.
- Review stability data packages and perform stability trending analysis.
- Author/review stability reports.
- Provide stability data to support regulatory filing.
- Lead the lab investigations related to stability testing and assist troubleshooting of lab equipment.
- Author procedures and work instructions related to Biologics GMP stability programs and GMP lab operations.
- Support analytical method qualification/validation as needed.
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
- Website
- http://www.nektar.com/
- Phone
- 415-482-5300
- Location
-
455 Mission Bay Blvd South
San Francisco
California
94158
United States
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