Scientist, Biologics Analytical Development (Potency Assay / Method Qualification)
Nektar Therapeutics
2021-12-03 07:37:29
San Francisco, California, United States
Job type: fulltime
Job industry: Science & Technology
Job description
Summary
Scientist I, Biologics Analytical Development, part of Nektar Biologics CMC organization is responsible for product characterization, analytical method development/qualification 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:
• Characterize protein polymer conjugates to elucidate conjugate sites and distribution
• Develop and validate analytical methods to support late stage drug development activities
• Assist process development scientists to characterize and monitor in-process purification
• Transfer analytical methods to internal QC group or CRO for drug substance and drug product release testing
• Summarize experimental data and write technical reports
Responsibilities
• Use 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
• May provide guidance to other lower level personnel
• Communicate cross-functionally with groups such as research, process development, formulation development, manufacturing, QC group and CRO/CMO to ensure appropriate project support
• Maintain a current knowledge of latest technological/scientific trends
Requirements
A PhD in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 2 years work experience in a research and/or development environment is required. Post-doctoral work may serve as experience. Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered.
• Must have extensive experience in analytical methods such as potency bioassays, plate-, and/or column-based methods for biologics is highly desirable
• Must have in-depth knowledge and hands-on experience in analytical method development, characterization, and/or GMP testing with primary focus on the development, method transfer, and qualification/validation for biologics
• 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.
• 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
Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents. Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function.