Scientist, Analytical Science and Technology na ProKidney

Position Summary:

The Scientist, Analytical Science and Technology (ASAT) role is responsible for executing analytical strategies/testing to support late-stage product development, method lifecycle management, and technology transfer for biologics and cell/gene therapy products. The primary location for this role is Morrisville location; however, this role will require travel to the Winston Salem location for the meetings, troubleshooting methods, and method validation activities.

Responsibilities:

• Perform laboratory bench work with focus on executing scientific experimentation for analytical method development, regent development, improvement and troubleshooting analytical methods.
• Perform experiments as needed to generate data for validations and other projects
• Perform data processing, evaluation and interpretation of experimental data, drawing conclusions based on the results. 
• Perform analytical testing of finished products and development samples. 
• Participate in analytical activities including method development, validation, and various analytical studies. 
• Assist in maintaining and updating all required SOP’s, test methods, protocols and reports.
• Present data at team and cross functional level on the current projects.
• Maintain current knowledge in the field of expertise and develop subject matter expertise with analytical technology.
• Perform overall lab support functions including routine maintenance of analytical instruments, ordering and maintaining inventory of sample, reagents and lab supplies. 
• The primary location for this role is Morrisville location; however this role will require travel to the Winston Salem location for the meetings, troubleshooting methods, and method validation activities.

 Qualifications:

• BS in Biochemistry or Biology science or relevant scientific field with a minimum of 5 years of relevant industry/academic experience in a laboratory environment.
• Prior working experience with multi-color flow cytometry, ELISA assays, and cell culture-based assays
• Experience in authoring test methods supporting Quality Control operations.
• Prior experience with conducting method development, and /or method validation is required.
• Experience in Gene and/or Cell therapy is desirable.
• Experience of using JMP or similar statistical tools is a plus
• Working knowledge and experience with good documentation practices in cGMP settings is a plus.
• Knowledge of ICH Quality Guidelines related to analytical method development and validation is desirable.