Scientist, Biologics (Stability)

Location
San Francisco, CA, United States
Posted
Jul 16, 2019
Ref
3563-394-NB
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

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.
A PhD in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 2 years work experience in a research and/or development environment is required. Post-doctoral work may serve as experience. Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered. Must be able to demonstrate success in technical proficiency, scientific creativity, collaboration with others and independent thought. Must be current in field, while able to demonstrate expert knowledge in scientific principles and concepts. Must be able to clearly communicate scientific information both written and oral with minimal assistance. Must be able to compose sound written work with no assistance. Must possess good oral & written communication skills. Must be able to demonstrate sound judgment. Must be able to demonstrate problem solving capabilities. Strong organizational skills are required. Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus. Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to laboratory practices are highly desired. Previous supervisory skills are a plus. Must be willing to work as part of a team. Must be able to demonstrate good interpersonal skills.

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.