Arcturus Therapeutics, Inc. is presently recruiting outstanding candidates with experience in the field of RNAi technologies and nanoparticle sciences. Only exceptional applicants need apply. Compensation and equity position is commensurate. Please email your resume to Careers@ArcturusRx.com.
Associate Scientist II, Analytical Development
The Associate Scientist II, Analytical Development will be responsible for development of analytical methodologies and conducting routine analytical characterization of formulated RNAs to support an emerging research pipeline focused on treating rare diseases.
- Develop analytical methodologies to characterize RNA based formulations using various chromatographic and spectroscopic techniques such as HPLC, UV-Vis, Fluorescence and LC-MS as well as other specialty instrumentation including but not limited to particle sizers, ELSD etc.
- Perform routine analytical testing on formulated RNAs using the above techniques
- Provide analytical support to formulation group in order to finalize formulation composition for new products
- Perform formulation stability studies including but not limited to pilot stability studies with proposed drug product configuration, contact material stability study, in-use compatibility study, accelerated stability studies etc.
- Maintain proper documentation of all experimental procedures and results
- Write/revise analytical methods, prepare technical reports and presentations which summarize procedures, study results, data interpretation as needed
- Perform calibration and routine maintenance of analytical equipment as per approved procedures
- Perform other duties as desired
- Must have a B.S. in Chemistry or related field with a minimum of 3 years of industrial hands on experience in analytical characterization of simple and complex RNA based formulations
- Solid knowledge and hands on experience in various chromatographic and spectroscopic techniques such as HPLC, LC-MS, UV-Vis, as well as other instrumentation such as particle sizers, ELSD, Osmometers, Viscometers etc.
- Must be highly motivated, an independent thinker with strong problem solving skills and great attention to details
- Comfortable working in a highly innovative environment and strong ability to cope with change.
- Responds well to scientific challenge and applies significant rigor to their own work.
- Will scientifically challenge others in a constructive manner and demonstrate exceptional team working skills.
- Excellent verbal and written communication skills
Manager/Senior Manager, Analytical Development
The Manager/Senior Manager, Analytical Development will play a critical role in leading development and utilization of analytical methods for characterization of RNA based drug substance/drug product candidates from an emerging research pipeline.
- Lead development of analytical methodologies and routine analysis of RNA based drug substance and drug product candidates from an emerging research pipeline
- Support testing needs of formulation development group on day to day basis from an early to late stage development.
- Evaluate, recommend, and implement new analytical technologies and instrumentation for characterization of RNA based drug substance and drug products
- Design and manage excipient, drug substance and drug product stability studies in support of research pipeline
- Present the challenges, experimental approaches, and results of analytical method development at internal meetings
- Author /Review analytical methods and technical reports
- Liaison with the internal tech transfer specialist for transfer of analytical methods for development stage candidates for analysis of excipients, drug substance, and drug product formulations as well as stability studies conducted at CMOs
- Author and review relevant CMC sections for US and ex-US regulatory filings
- Ph.D degree in Chemistry, Analytical chemistry or related discipline with 7-10+ years’ experience in an analytical laboratory
- Solid background and experience in analytical method development and characterization of RNA based drug substance and drug products including complex lipid nanoparticle formulations
- Strong experience in various chromatographic and spectroscopic techniques such as HPLC, LC-MS, UV-Vis, as well as other specialty instrumentation including but not limited to particle sizers, ELSD, CAD etc.
- Instrument Integration Experience with aspects of method development relevant to manufacturing applications such as GMP/GLP, method qualification 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
- Demonstrated experience in management of a laboratory operation including supervisory experience
- Excellent communication of technical and operational activities verbally and in writing
- Demonstrated ability to work as part of a cross-functional team