Scientist II, Biologics Analytical Development

The Scientist II position is part of the early-stage Analytical Development group, which is part of the Analytical Development organization at Nektar. This group is responsible for analytical support of bioprocess development and process characterization of Nektar’s biologics pipeline products.

The preferred candidate provides timely information in context to bioprocess development groups to enable their decision making and will be actively involved in projects in all clinical phases.  Analytical support includes the exercise of technical discretion in the execution and interpretation of experiments, providing and presenting scientific data to process scientists, generating technical documents with a scientific discipline, and demonstrating a high level of professional expertise through familiarity with analytical instrumentation and bioanalytical assays.

Key Responsibilities:

• Develop, qualify and troubleshoot chromatography (HPLC, UHPLC) and CE (icIEF and CE-SDS) based methods. Immunoassay (ELISA and western blots) experience is desired, but not required.
• Experience in developing high throughput analytical assays for bioprocess projects is highly desired.
• Evaluate suitability of new methods and qualify methods for intended uses. Author method development and qualification reports and SOPs for test methods. Serve as trainer and provide technical guidance for junior analysts.
• Provide analytical support for bioprocess development. Prepare technical reports and data summaries in a timely manner. Maintain accurate and well-organized laboratory records.
• May serve as a primary contact person for cross-functional projects and be accountable for key deliverables. Effective communication skills and ability to work with cross-functional teams are essential.
• Contribute to the development and/or improvement of technical capabilities within Analytical Development as well as initiatives to improve group efficiency.

Requirements

A PhD in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 4 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 have extensive experience in HPLC analysis of proteins, such as ion exchange, reversed phase, and size exclusion chromatography, and capillary electrophoresis for proteins is highly desirable
• Must have in-depth knowledge and hands-on experience in analytical method development and characterization for biologics
• Must be able to demonstrate potential for technical proficiency, scientific creativity, collaboration with others and independent thought
• Must be able to clearly communicate scientific information both written and oral.
• Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors
• Experience in technology transfer to internal QC lab or CRO in support of drug substance/drug product release testing is highly desirable
• Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus
• Must be willing to work as part of a team