Sr. Scientist, Safety Assessment (Immunogenicty Assessment)

Location
San Francisco, CA, United States
Posted
Sep 06, 2018
Ref
3237-520-2018
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

This position contributes to and supports the company's research and development activities to create high value therapeutics to address unmet medical needs.

The Sr. Scientist, Toxicology, will contribute to the design, validation, and implementation of studies to assess immunogenicity of PEGylated therapeutics in discovery, preclinical and clinical samples in both the regulated and non-regulated environment. Provide technical/scientific guidance and leadership to the global toxicology team to assure proper implantation and execution of immunogenicity studies. Act as research scientist, in a team setting, actively participating in project team activities. Responsible for reporting and interpreting bioanalytical results to support drug discovery and development activities.

The successful candidate will: Design, qualify and validate immunogenicity assays; coordinate these activities with Nektar Bioanalytical Development group and CRO. Summarize study results, prepare departmental immunogenicity risk assessments, and write technical reports in support of drug discovery, development, and regulatory filing. Represent toxicology department in 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. Additional responsibilities include: Works on complex problems in which analysis 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 research, preclinical, and clinical development to ensure appropriate project support. Maintaining a current knowledge of latest technological/scientific trends.

Requires a PhD in a relevant scientific discipline (Biology, Immunology, Biochemistry, Chemistry, Cell Biology, etc) with a minimum of 5 years related experience, may include post doctoral experience. Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered. Understanding of the immune system, antibody assays, and experience with clinical and preclinical studies is required. Must have in-depth knowledge and hands-on experience in development, execution and troubleshooting of anti-drug antibody assays. Knowledge of GLP, GCP, Bioanalytical and Immunogenicity Guidance (FDA/EMA) is essential. Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to laboratory practices are highly desired. 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. 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 goal-oriented, quality-conscientious, and customer-focused. Must be experienced in working in a team-focused environment.

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.