Sr. Scientist II, Analytical Development and Characterization/Mass Spectrometry

The Sr. Scientist II (Analytical Development and Characterization/Mass Spectrometry), part of Nektar's Biologics CMC organization, is responsible for product characterization, analytical method development of proteins and protein-conjugates for Nektar Biologic products in pre-clinical and clinical development stages.  The candidate will collaborate with other groups on analytical issues, develop testing methodologies to support process development of drug substance and drug product.

The successful candidate will have extensive expertise in developing LC-MS/MS based protein characterization methods. A self-starter with the ability to work independently under minimal supervision, and who is seeking to be part of an authentic, innovative and fast-paced team. The ideal candidate will be instrumental in bringing the company’s therapeutic products from early-discovery development stage to commercial launch and be a critical part of creating an innovative team for the development of the company’s next generation products

Responsibilities:

The candidate will develop mass spectrometry methods to support late-stage drug development activities, including extended product characterization, comparability, process characterization and process validation.

• Develop and qualify LC-MS/MS methods to support drug development activities.
• Perform in-depth characterization for protein and protein polymer conjugates using various analytical techniques.
• Author, update, and revise CMC regulatory filing sections to support regulatory filings. Address CMC comments regulatory responses.
• Oversight and management of junior level scientists. Provide technical review of analytical data and laboratory documentation, method development reports and method validation protocols/reports.
• Proactive engagement to identify projects and areas for continuous improvement purposes.
• Maintain and troubleshoot Orbitrap/QTOF mass spectrometers and Waters UPLC

Hands-on experience on sample preparation for mass spectrometry-based analysis of proteins. Experience in maintaining and troubleshooting UPLC and mass spectrometers. Experience in the analysis of PEGylated proteins and glycoproteomics is a plus.

Minimum Qualification Requirements:

A PhD in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 8 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 significant success in technical proficiency, scientific creativity, collaboration with others and independent thought. Must be current and active in field, while able to demonstrate expert knowledge in scientific principles and concepts both internally and externally with sustained performance and accomplishment. Must be able to clearly communicate scientific information both written and oral. Must be able to compose sound written work. Must possess good oral and written communication skills. Ability to present technical information to both technical and non-technical audiences is required. 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 management skills are a plus. Must be willing to work as part of a team. Must be able to demonstrate good interpersonal skills.

Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents. Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function.