Scientist, Biologics Analytical Development
The Scientist position is in the Analytical Method Qualification/Stability group, which is part of the Biologics Analytical Development organization in Nektar. This group is responsible for analytical method development, optimization, qualification, and non-GMP stability testing (in a GMP like environment) of Nektar’s biologics pipeline products. The preferred candidate will possess prior knowledge and experience in HPLC/CE method development and validation. As a Scientist, you will provide technical expertise, analytical support, and exercise of technical discretion in the execution and interpretation of experiments, providing and presenting scientific data to analytical sub teams, generating technical documents with a scientific discipline, and demonstrating a high level of professional expertise through familiarity with analytical instrumentation and bioanalytical assays.
Essential Duties and Responsibilities:
- Independently develop, qualify, validate and troubleshoot chromatography (HPLC, UHPLC) and CE (icIEF and CE-SDS) based methods.
- Evaluate suitability of new methods and qualify methods for intended uses.
- Independently plans and executes experiments that support development activities and project goals.
- Maintain a high level of productivity in the lab and adhere to project timelines.
- Prepare technical reports and data summaries in a timely manner. Maintain accurate and well-organized laboratory records (Electronic Notebooks).
- Independent use of Empower chromatography software to set up projects, create custom fields, acquire, review and process data and generate custom reports.
- Troubleshoots analytical methods and lab instrumentations.
- Maintain and manage method qualification/stability lab.
- Author method development and qualification reports and test methods.
- Serve as trainer and provide technical guidance for junior analysts.
- 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.
- Maintains compliance to company Environmental Health and Safety policies, procedures and practices.
Minimum Qualification Requirements:
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 have a strong QC background with experience in analytical method development and/or validation in the biotech/pharmaceutical industry. Must be able to demonstrate hands-on technical proficiency, scientific creativity, collaboration with others and independent thought. Must be able to clearly communicate scientific information both written and oral with minimal assistance. Must be able to compose sound written work with minimal assistance. Must possess good oral and 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. Prior knowledge and experience with chromatography systems such as Empower is highly desirable. Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to laboratory practices are highly desired. Must be willing to work as part of a team. Must be able to demonstrate good interpersonal skills. Experience in developing high throughput analytical assays for bioprocess projects is highly desired.
Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices. 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 must be able to wear a respiratory protection (filtering facepiece, 1/2 face, full-face, or powered air purifying respirator, supplied air, or self-contained breathing apparatus) for certain tasks essential to the job function. 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. Employees must be able to maneuver themselves under 30 inch clearances. Employees must be able to able to accurately detect color and have 20/20 vision (with/without corrective lenses).