This role will be responsible for product characterization, analytical method development/validation of proteins and protein-conjugates for Nektar Biologic products in pre-clinical and clinical development stages. Conducts and collaborates with others on analytical issues relevant to long-term objectives and concerns.
Develops testing methodologies to support process development of drug substance and drug product. This position contributes to and supports the company's research development and manufacturing to create high value therapeutics to address unmet medical needs.
The successful candidate will be responsible for:
Developing and validating analytical methods to support early stage drug development activities
Characterization of protein polymer conjugates to elucidate conjugate sites and distribution
Assist Process Development Scientists in characterizing and monitoring in-process purification
Transfering analytical methods to internal QC group or CROs for drug substance and drug product release testing
Summarizing experimental data and writing technical reports
Additional responsibilities include: Using professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
May determine methods and procedures on new assignments and recommend new methods and procedures. Communicate cross-functionally with groups such as Research, Process Development, Formulation Development, Manufacturing, QC group and CRO/CMOs to ensure appropriate project support. Maintain current knowledge of latest technological/scientific trends.
Requires a PhD in a scientific discipline and a minimum of 2 years related experience, may include post-doctoral experience. Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered.
Must have in-depth knowledge and hands-on experience in analytical method development and characterization for biologics Must have extensive experience in different HPLC separation methods such as ion exchange, reversed phase, and size exclusion chromatography for proteins. Must be able to demonstrate potential for technical proficiency, scientific creativity, collaboration with others and independent thought. Must be able to clearly communicate scientific information both written and oral.
Experience in mass spectrometry and capillary electrophoresis analysis of proteins is highly desirable. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Experience in technology transfer to internal QC lab or CRO in support of drug substance/drug product release testing is highly desirable.
Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus. Must be willing to work as part of a team.