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Sr. Scientist, Analytical Ultracentrifugation (AUC)

King of Prussia, PA, US
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Summary

The Senior/Scientist, Analytical Ultracentrifugation (AUC) position conducts and provides technical guidance on AUC or other biophysical method development and validation projects. The Senior/Scientist, AUC will perform troubleshooting for AUC and other instruments, methods, and procedures, and will be responsible for writing protocols and reports. The role will also assist others in performing routine maintenance and troubleshooting on AUC or other biophysical instruments methods and procedures. The Scientist will be required to design and execute method development/validation independently and interpret and review analytical data for self and other team members.

Responsibilities

·Independently performs AUC development/optimization/validation and conduct routine AUC testing for AAV or other biologics products

·Trains junior scientists in AUC or other biophysical technologies

·Designs and executes experiments independently for self and others

·Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents

·Leads analytical (procedural and instrumental) troubleshooting sessions Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities

·Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP)

·Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers

Qualifications

·Bachelor’s degree, or equivalent and relevant previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 4 years or Master’s degree with 3 years of experience or PhD with 1 year of experience

·Demonstrated ability to apply AUC to analyze gene therapeutic products and other biologics Extensive hands-on experience in performing and trouble-shooting AUC technique, preferred using SEDFIT software for data analysis

·Experience with other biophysical technologies is a plus Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidanceFull knowledge of technical operating systems

·Ability to independently optimize analytical methods

·Ability to independently perform root cause analysis for method investigations Proven technical writing skills Proven problem solving and troubleshooting abilities. Effective written and oral communication skills as well as presentation skills Time management and project management skills Ability to mentor others on technical operating systems Ability to independently review and understand project proposals/plans. Ability to work in a collaborative work environment with a team

Sr. Scientist, Analytical Ultracentrifugation (AUC)

King of Prussia, PA, US
Apply Now >