Arcturus Therapeutics
Senior Manager, Analytical Development
Arcturus Therapeutics, California, Missouri, United States, 65018
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Senior Manager, Analytical Development
role at
Arcturus Therapeutics
SUMMARY:
The Senior Manager, Analytical Development and QC, will play a critical role in providing guidance and direction to our experienced AD/QC group. In this role, you will provide development and utilization of analytical methods for characterization of RNA based drug product candidates from an emerging research pipeline.
RESPONSIBILITIES:
Evaluate, recommend, and implement new analytical technologies and instrumentation for characterization of lipids.
Closely work with the broad team of chemistry, RNA and formulation scientists to design and execute specific laboratory studies/experiments to guide process development and process optimization efforts.
Provide strategies and manage validation of analytical methods for candidates at all stages for analysis of excipients at CMOs.
Manage qualification of analytical methods for CoA verification of excipients at CMOs.
Present the challenges, experimental approaches, and results of analytical method development at internal meetings.
Review SOPs, validation protocols, validation reports, and related documents from CMOs/CROs.
Author /Review analytical methods and technical reports.
Author /Review CMC section of regulatory filing documents.
REQUIREMENTS:
Ph.D. degree in Chemistry, Analytical chemistry, or related discipline with 0-3 years of relevant work experience for Scientist I, 3-8 years of relevant work experience for Scientist II, 8-10+ years’ experience for Sr. Scientist
Strong experience in various chromatographic and spectroscopic techniques such as HPLC, LC-MS, HS-GC, GC-MS, FTIR, KF and UV-Vis, as well as other specialty instrumentation including but not limited to ELSD, CAD etc. Familiarity with instrumentation software including Chemstation, ECM OpenLab, Chromeleon and Xcalibur software is a plus.
Working knowledge of NMR, ICP-MS, endotoxin and bioburden
Experience in the field of RNA based drug substance and drug products including complex lipid nanoparticle formulations is a plus.
Strong experience with aspects of method development relevant to manufacturing applications such as GMP, method qualification/validation/verification and robustness testing, process analytical technologies, method transfer best practices, quality systems, documentation.
Proven ability to identify and resolve technical problems by application of scientific principles and established analytical techniques in the field to meet strict reporting deadlines.
Excellent communication of technical and operational activities verbally and in writing.
Demonstrated ability to work as part of a cross-functional team.
WHAT WE OFFER
An exciting opportunity to join a company that offers a competitive total rewards package that includes:
Free variety of snacks and beverages
On Campus Gym
Company sponsored FUN events
For a deeper dive into our company and corporate culture visit www.ArcturusRx.com
#J-18808-Ljbffr
Senior Manager, Analytical Development
role at
Arcturus Therapeutics
SUMMARY:
The Senior Manager, Analytical Development and QC, will play a critical role in providing guidance and direction to our experienced AD/QC group. In this role, you will provide development and utilization of analytical methods for characterization of RNA based drug product candidates from an emerging research pipeline.
RESPONSIBILITIES:
Evaluate, recommend, and implement new analytical technologies and instrumentation for characterization of lipids.
Closely work with the broad team of chemistry, RNA and formulation scientists to design and execute specific laboratory studies/experiments to guide process development and process optimization efforts.
Provide strategies and manage validation of analytical methods for candidates at all stages for analysis of excipients at CMOs.
Manage qualification of analytical methods for CoA verification of excipients at CMOs.
Present the challenges, experimental approaches, and results of analytical method development at internal meetings.
Review SOPs, validation protocols, validation reports, and related documents from CMOs/CROs.
Author /Review analytical methods and technical reports.
Author /Review CMC section of regulatory filing documents.
REQUIREMENTS:
Ph.D. degree in Chemistry, Analytical chemistry, or related discipline with 0-3 years of relevant work experience for Scientist I, 3-8 years of relevant work experience for Scientist II, 8-10+ years’ experience for Sr. Scientist
Strong experience in various chromatographic and spectroscopic techniques such as HPLC, LC-MS, HS-GC, GC-MS, FTIR, KF and UV-Vis, as well as other specialty instrumentation including but not limited to ELSD, CAD etc. Familiarity with instrumentation software including Chemstation, ECM OpenLab, Chromeleon and Xcalibur software is a plus.
Working knowledge of NMR, ICP-MS, endotoxin and bioburden
Experience in the field of RNA based drug substance and drug products including complex lipid nanoparticle formulations is a plus.
Strong experience with aspects of method development relevant to manufacturing applications such as GMP, method qualification/validation/verification and robustness testing, process analytical technologies, method transfer best practices, quality systems, documentation.
Proven ability to identify and resolve technical problems by application of scientific principles and established analytical techniques in the field to meet strict reporting deadlines.
Excellent communication of technical and operational activities verbally and in writing.
Demonstrated ability to work as part of a cross-functional team.
WHAT WE OFFER
An exciting opportunity to join a company that offers a competitive total rewards package that includes:
Free variety of snacks and beverages
On Campus Gym
Company sponsored FUN events
For a deeper dive into our company and corporate culture visit www.ArcturusRx.com
#J-18808-Ljbffr