Sr. Scientist (Bioanalytical Method Development)
Senior Scientist/scientist, Bioanalytical Development, will contribute to the development, validation, and implementation of ligand-binding assays (LBA) for quantifying biotherapeutic proteins, biomarkers, and assessing immunogenicity in discovery, preclinical and clinical samples in both the regulated and non-regulated environment. Provide technical/scientific guidance and leadership to the global bioanalytical team to assure proper implantation, and execution of complex bioanalytical methods. Act as research scientist, in a team work setting, to actively participate in project team activities, and is responsible for reporting and interpreting bioanalytical results to support drug discovery and development activities.
The successful candidate will be responsible for:
• Develop, qualify and validate PK/PD/immunogenicity assays and perform subsequent analysis of PK/PD study samples
• Summarize bioanalytical results, prepare departmental SOPs, and write technical reports in support of discovery screening and regulatory filing.
• Represent bioanalytical department to participate cross-functional discussions and present scientific findings at the team meetings.
• Oversee cross-site method transfer and outsourcing efforts to allow timely bioanalytical support for research and development activities.
This position contributes to and supports the company’s research and development activities to create high value therapeutics to address unmet medical needs.
Additional responsibilities include:
• Works on complex problems in which bioanalysis of situations or data require an in-depth evaluation of various factors
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
• May determine methods and procedures on new assignments and recommend new methods and procedures
• Serves as an in-house consultant
• Regularly interacts with senior management
• Communicate cross-functionally with groups such as research, preclinical and clinical development to ensure appropriate project support
• Maintaining a current knowledge of latest technological/scientific trends
• Normally requires a PhD in a relevant scientific discipline (Biology, Immunology, Biochemistry, Chemistry, Cell Biology, etc) with a minimum of 5 (scientist) or 8 (senior scientist) years related experience, may include post doctoral experience.
• Must have in-depth knowledge and hands-on experience in ligand-binding assay (LBA) development, execution and troubleshooting.
• Expert knowledge of methods and immunoassay technologies, such as ELISA (direct and indirect sandwich formats), Luminescence, Colorimetric, Electrochemiluminescence (MSD), etc to support animal and clinical studies.
• Understanding of the immune system, antibody assays, and experience with clinical and preclinical studies is required.
• Experience with developing automated sample handling and assay processes is desirable. Knowledge of GLP, GCP, Bioanalytical and Immunogenicity Guidance (FDA/EMA) is desirable.
• A working knowledge of protein biochemistry and characterization would be beneficial. Strong verbal and written communication skills are required.
• Must be goal-oriented, quality-conscientious, and customer-focused.
• Good compliance and safety practices are a must.
• Must be experienced in working in a team-focused environment.
• Knowledge and experience in LC-MS/MS bioanalytical method development and sample analysis is a plus
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.