Nektar has an exciting opportunity for a Sr. Scientist with hands-on experience in ELISA / ECL based PK / PD / ADA assay development.
Provide technical oversight within the Biologics group in Bioanalytical R&D.
Extensive hands on experience in quantitative assay development in large molecules
Proven success in managing multiple projects and working with cross-functional teams
Trouble shooting and problem-solving strength
Ability to develop Ligand binding assays in biological matrices.
Develop and qualify ELISA / ECL based PK / PD / ADA assays to support preclinical and clinical studies, drug safety evaluations.
Develop protocol for sample preparation and analysis of assays.
Familiarization with GLP and GCP guidelines, white papers and industry practices.
Identify and develop appropriate immunoassays for new chemical entities and biomarkers on ELISA, MSD platform, and other methods to quantify proteins in complex matrices such as plasma or serum.
Independently design and conduct experiments and interpret and summarize data.
Develop robust immunoassays or other assays to quantify challenging protein-polymer conjugates. Must be able to bring creativity to assay development work.
Collaborate with members of the Protein Therapeutics and Bioanalytical teams and interface with Research Biology and Pharmacology.
Program and validate liquid handling systems for high throughput assay methods.
Ensure assay robustness to allow successful inter lab transfer for GLP assay development.
Work with CROs to generate necessary antibodies.
Synthesize and interpret results anticipate and understand caveats and issues related to the assay.
Participate in and present data to project teams. Communicate with research management on a regular basis and assist with development of research goals and strategies.
May train / manage / supervise RAs and Scientists to perform routine bioanalytical lab operation.
Ensure activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, and regulatory guidance.
Ph.D in Biochemistry, Biotechnology, Protein Chemistry, Analytical Biochemistry, Bio-Analytical / Analytical Chemistry or related area from a reputed institute.
Minimum work experience in a research and / or development environment is required. 6-10 years for Ph.D and 15+ years for Masters Degree with demonstrated capabilities and / or significant experience may also be considered.
Must be comfortable with standard protein chemistry and biochemical methods such as Bradford or BCA protein quantitation.
Demonstrated expertise in a broad range of assay and immunoassay techniques, including excellent liquid handling skills, both manual and robotic.
Demonstrated capabilities with a variety of robotic liquid handling systems, including programming and testing, in addition to producing results.
Hands on experience on LC-MS / MS and electronic data management like LIMS will be considered an added advantage
Knowledge of Good Laboratory Practices (GLP) procedures and bioanalysis related guidance documents on OECD, USFDA and EMA.
Must be detail-oriented and able to conduct experiments in a precise and accurate manner.
Demonstrated ability to develop quantitation assays for atypical protein analytes.
Must be comfortable working with CROs and developing appropriate documentation for technology transfer.
Demonstrated computer and data analysis skills. Must be able to present and summarize data.
Demonstrated intellectual leadership, creativity and strategic thinking within his / her area of expertise.
Excellent communications, interpersonal skills and organizational skills.
Ability to work well within a team as well as independently