Sr. Scientist
Nektar Therapeutics
Hyderabad, India, United States
6d ago

Position Overview

Nektar has an exciting opportunity for a Sr. Scientist with hands-on experience in ELISA / ECL based PK / PD / ADA assay development.

Responsibilities

  • 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.
  • Requirements :

  • 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
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