Founded in 2013 and based in San Diego, Arcturus Therapeutics Ltd. (NASDAQ:ARCT) is an RNA medicines company with enabling technologies – UNA Oligomer chemistry and LUNAR® lipid-mediated delivery. Arcturus’ diverse pipeline of RNA therapeutics includes programs pursuing rare diseases, Hepatitis B, non-alcoholic steatohepatitis (NASH), cystic fibrosis, and vaccines. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of RNA medicines including small interfering RNA, messenger RNA, replicon RNA, antisense RNA, microRNA and gene editing therapeutics. Arcturus owns LUNAR® lipid-mediated delivery and Unlocked Nucleomonomer Agent (UNA) technology including UNA Oligomers, which are covered by its extensive patent portfolio (140 patents and patent applications, issued in the U.S., Europe, Japan, China and other countries). Arcturus’ proprietary UNA technology can be used to target individual genes in the human genome, as well as viral genes, and other species for therapeutic purposes. Arcturus’ commitment to the development of novel RNA therapeutics has led to partnerships with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, Synthetic Genomics Inc., CureVac AG and Cystic Fibrosis Foundation Therapeutics Inc. For more information, visit www.Arcturusrx.com, the content of which is not incorporated herein by reference.
Arcturus Therapeutics, Inc. is presently recruiting outstanding candidates with experience in the field of RNA technologies and nanoparticle sciences. Our corporate culture is dynamic, diverse, and creative. We value collaboration and teamwork. We seek individuals to join us with a genuine passion for the science behind helping to cure disease and improve the lives of patients. Please email your resume to Careers@ArcturusRx.com.
Associate Director, Formulations/Process Development
The Associate Director, Formulations Development will be responsible for designing, directing, planning, coordinating and troubleshooting all aspects of formulations development from early lead optimization to late stage development.
- Must have a PhD in Chemistry or pharmaceutical sciences with more than 8 years of direct industrial experience in design and development of nanoparticle-based drug delivery systems for nucleic acids.
- Expertise in developing liquid, frozen and lyophilized formulations of lipid based nucleic acid formulations.
- Expertise and knowledge in scale up of formulation production and purification unit operations and tech transfer activities.
- Must be an independent thinker with a passion for developing innovative formulation technologies.
- Must possess excellent scientific publication and patent record in the field of lipid nanoparticle based drug delivery systems.
- Must possess exemplary leadership and mentoring skills and related management experience
- Must possess in depth understanding of all aspects of formulation development as well as downstream characterization including physico-chemical, stability and biological evaluation.
- Experience in writing pharmaceutical development sections of regulatory filings (IND, NDA etc.)
- Strong background and expertise in designing in vitro and in vivo bio-evaluation assays for screening novel drug delivery systems is desirable.
- Thorough knowledge and understanding of PK/PD aspects of lipid nanoparticle-based formulations is highly desired.
- Excellent oral and written communication skills are necessary for this position.
Senior Manager/Engineer, Manufacturing Tech Service
Arcturus is seeking a Senior Manager/Engineer to manage contract manufacturing operations and technology transfer for mRNA drug substance. A successful candidate in this role will be responsible for managing technology transfer of manufacturing processes to contract manufacturing organizations (CMOs) and management of GMP manufacture for clinical supply of RNA drug substances. The candidate will also support internal and external process development activities, CMO due diligence, process scale up, data trending activities, and regulatory filings. Additionally, the candidate will be required to resolve complex manufacturing issues through collaboration with the process development and manufacturing teams. They will work closely with a team of highly motivated scientists and engineers in the RNA production and analytical sciences group to enable successful GMP manufacture of mRNA drug substance.
- Degree in relevant engineering discipline: Ph.D. with 5+ years, MS with 9+ years, or BS with 12+ years of relevant development or engineering experience in the pharmaceutical or biotechnology industry
- A broad understanding of process engineering/development of biologic or nucleic acid drug substance
- Demonstrated ability to manage technology transfer and scale up of drug substance manufacturing processes
- Experience managing GMP manufacturing operations for clinical or commercial drug substance
- Proven ability to work in a team environment to solve complex technical and equipment qualification challenges
- Experience working with nucleic acid products is a plus
- Proficiency with quality by design concepts, mathematical modeling software for design of experiments and data trending, statistical process control, and complex data analysis
- Knowledge of relevant cGMP and quality guidelines
- Ability to effectively represent Arcturus with external partners
- Experience in providing scientific/technical due diligence support for business development activities
- Excellent oral and written communication skills
- Travel to contract manufacturing sites to support manufacture and technology transfer is required
Senior Program Manager
Arcturus is seeking a Senior Program Manager to work with our team members to develop and maintain a Master Program Plan, to facilitate processes for handling risks, issues, scope, budgeting, expense tracking, and to document project communications, meetings, and decisions.
- Develop detailed program plans, budgets, and assignment of resources in collaboration with the functional leads of the Manufacturing, Pharmacology, and In vitro Screening units.
- Establish and maintain integrated project schedules to ensure accurate program, financial and portfolio analyses can be performed.
- Facilitate program team meetings, cross-functional information sharing and ensures alignment.
- Balance conflicting priorities across multiple objectives or programs and has the ability to articulate risks and trade-offs.
- Effectively communicate with all levels within the organization, documents and maintains project team meeting outcomes, activities and decisions.
- Build strong working relationships across departments, with key stakeholders and external collaboration partners.
- BS/MS in cell biology, molecular biology, chemistry or other relevant science discipline with 5+ years of experience in the pharmaceutical or biotechnology industry as a Project Manager
- Experience with managing a R&D program from Discovery Phase through to IND/CTA submission
- Strong attention to detail with excellent record-keeping and reporting skills
- Adept at common software suites (e.g. Microsoft Office, especially MS Project)
- Ability to manage time and support multiple Programs in a fast-paced Biotech environment
- Exceptional written/oral communication skills.
Arcturus is seeking a Research Assistant to work with our RNA Sciences team. This is an excellent entry-level opportunity!
- Lead required lab activities for RNA targets including cloning and production of plasmid constructs;
- Develop biochemical assays, producing and purifying RNA;
- Support process development for clinical RNA manufacture;
- Prepare detailed standard operating procedures for technology transfer.
- Bachelor’s degree in molecular biology, biochemistry, pharmaceutical sciences, biological sciences, chemistry, chemical engineering, or other relevant discipline;
- Demonstrated ability in data analysis with statistical methods;
- Demonstrated ability in problem solving and organization;
- Detail oriented;
- Excellent written and oral communication skills;
- Some experience with traditional and modern molecular biology techniques, such as plasmid isolation and RNA purification, molecular cloning (restriction enzyme-based & seamless), PCR, qPCR, RT-qPCR, Western, and ELISA is a plus;
- Some experience working with RNA, in vitro transcription/translation is a plus.
Senior Research Associate, Analytical Development
The Sr. Research Associate, Analytical Development will be responsible for routine analytical testing of RNA-based drug substances, intermediates and formulated drug products as well as for development and optimization of analytical methodologies to support an emerging research pipeline focused on treating rare diseases.
- Work in close collaboration with the broad team of RNA, chemistry and formulation scientists, to design and perform laboratory research experiments needed to support RNA, chemistry and formulation process development efforts.
- Conduct, manage and coordinate routine analytical testing of RNA-based drug substances, intermediates and formulated drug products using various analytical techniques such as HPLC, LC-MS, UV-Vis, Fluorimetry as well as other specialty instrumentation including but not limited to particle sizers, KF, osmometer, etc..
- Participate in development, optimization and trouble-shooting of the analytical methodologies to characterize RNA-based API and drug product formulations.
- Support analytical equipment maintenance, trouble shooting and qualifications.
- Support organizing, storage and maintaining inventory of the analytical materials and supplies.
- Maintain proper documentation of all experimental procedures and results.
- Write/revise analytical methods, prepare technical reports and presentations which summarize procedures, study results and provide data interpretation.
- Present scientific results and observations to colleagues, management and clients at internal and client meetings.
- Provide necessary training, guidance and oversight for analytical research associates and interns.
- Perform other duties as needed.
- Bachelors degree in Analytical Chemistry or in related discipline with 5+ years of relevant work experience or Masters degree in a related area of science with 0-2 years of relevant experience.
- Solid knowledge and hands-on experience with HPLC, LC-MS and LC-MS/MS instrumentation and applications.
- Familiarity with instrumentation software including Chemstation, ECM OpenLab, Chromeleon and Xcalibur software is a plus.
- Expertise in multiple analytical techniques such as UV-Vis, Karl Fischer, fluorescent plate readers, osmometers, viscometers etc.
- Experience with analytical characterization of nucleic acid based therapeutics is a plus.
- Knowledge of biochemistry techniques such as qPCR and various gel-based assays (e.g. Western blot) is a plus.
- Familiarity with development, optimization and qualification of analytical procedures.
- Ability to apply existing knowledge and experience to solve standard analytical problems without instruction and receive guidance on new assignments or more complex problems from a senior team member or supervisor.
- Ability to think critically and creatively, have great attention to details.
- Have strong organizational and planning skills.
- Able to work independently and collectively as part of an integrated team environment with extensive interactions with RNA production, formulation, chemistry and CMC groups.
- Comfortable working in a highly innovative environment and strong ability to cope with change.
- Excellent verbal and written communication skills.