Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is an RNA medicines company with enabling technologies – LUNAR® lipid-mediated delivery, Unlocked Nucleomonomer Analog (UNA) chemistry, STARR™ technology – and mRNA drug substance along with drug product manufacturing. Arcturus’ diverse pipeline of RNA therapeutics includes programs to potentially treat Ornithine Transcarbamylase (OTC) Deficiency, Cystic Fibrosis, Glycogen Storage Disease Type 3, Hepatitis B, and non-alcoholic steatohepatitis (NASH). Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (182 patents and patent applications, issued in the U.S., Europe, Japan, China and other countries). Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, CureVac AG, Synthetic Genomics Inc. and the Cystic Fibrosis Foundation. For more information visit www.Arcturusrx.com
Arcturus Therapeutics is presently recruiting outstanding candidates with experience in the field of mRNA 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
Research Associate / Senior Research Associate, Drug Discovery
We are looking for a Research Associate / Senior Research Associate to join our growing team. The Research Associate will conduct hands-on experiments in the Drug Discovery department with a wide variety of cellular biology, molecular biology, and biochemistry techniques. This person will be expected to complete scientific and technical tasks on aggressive timelines and to work as part of a team on varied projects with changing priorities. This position requires excellent communication skills, an outstanding ability to troubleshoot technical issues, a superior ability to plan and carry out experiments independently, and to work with complex instrumentation and software. Exact title and responsibilities will be commensurate with experience.
- Coordinate with team members to define experiments, plan to achieve objectives and execute work with limited supervision.
- Process in vivo samples for molecular biology assays (protein, RNA and DNA analysis).
- Grow, maintain and transfect mammalian cells.
- Perform initial analysis of experimental data and interpret immediate outcomes.
- Troubleshoot routinely technical problems and perform ordinary/extraordinary equipment maintenance.
- Contribute to the development of novel assays.
- Demonstrate clear communication and present scientific results in department meetings.
- Order and maintain reagents and lab supply.
- Ability to keep organized data and records.
- Performs other duties as assigned.
- Bachelor/Master degree in cellular biology, molecular biology, biochemistry, or a related field.
- 3-5 years of relevant laboratory experience in academic or industrial setting.
- Strong experience with micropipetting, aseptic/sterile technique and plating.
- Experience with BSL-2 procedures.
- Experience with animal tissue and blood samples for DNA, RNA and protein isolation.
- Experience with mammalian cell culture and transfection techniques.
- Experience with protein characterization assays (BCA, SDS-PAGE, Western Blot, In Cell Western, and ELISA).
- Experience with nucleic acid characterization assays (PCR, TaqMan qPCR, and QuantiGene).
- Strong computer skills, including MS Word, Excel, PowerPoint and data analysis software (Prism).
- Experience with high throughput screening is a plus.
- Experience with lipid nanoparticle delivery systems is a plus.
Scientist I/II, Translational Biology (In Vivo)
We are seeking an experienced in vivo pharmacology scientist to support preclinical stage programs through the management, design, planning, and execution of in vivo studies.
- Design, execute and interpret preclinical in vivo studies in support of multiple programs.
- Manage pharmacology research studies at CROs or external collaborators.
- Lead in vivo model development and characterization of multiple programs.
- Work closely with internal teams to conduct in vivo studies, coordinating tasks across multiple projects, demonstrating prioritization and planning.
- Maintain vivarium operations and IACUC related Animal Care and Use Protocols (ACUPs), including creating and revising protocols and amendments.
- Maintain and initiate new mouse colony lines (KO, Transgenic) at CROs.
- Ph.D. degree required in a scientific discipline or requires a MA/MS with appropriate work experience with more than 5 years of work experience in a research and/or development environment.
- Extensive murine experience in hands-on administration of drug therapeutics via various routes, including IV, PO, IP. CNS and Lung delivery routes are a plus.
- Hands-on familiarity with ELISA, enzymatic activity assays, PCR, Western Blot.
- Experience in managing external research (Academic, CRO).
- Experience in providing management, mentoring and training to associates with respect to in vivo and ex vivo pharmacology workstreams.
- Familiarity with liver and lung disease murine models.
- Proficiency in the use and development of new mouse models.
- Prior experience with nucleic acid therapy and lipid nanoparticle delivery is a plus.
- Knowledge in the therapeutic targeting of the tumor microenvironment is a plus.
- Comfortable in a fast-paced small biotech environment.
- Excellent organization skills with strong attention to detail.
- Excellent oral and written communication skills.
Research Associate, Analytical Development:
The Research Associate, Analytical Development will be responsible for conducting routine analytical characterization of RNA drug substances, intermediates and formulated drug products to support an emerging research pipeline focused on treating rare diseases. The candidate will also assist with optimization, development and implementation of new analytical procedures as needed.
- Perform 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 the development, optimization, and trouble-shooting of the analytical methodologies to characterize RNA-based API and drug product formulations
- In close collaboration with the broad team of RNA, chemistry and formulation scientists, design and perform laboratory research experiments needed to support RNA, chemistry and formulation process development efforts
- 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
- Routine maintenance of equipment.
- Assist in the inventorying and ordering of reagents and other laboratory supplies.
- Perform other duties as needed
- Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology, Pharmaceutical, Life Science, or equivalent.
- Familiarity with one or more chemical and biochemical techniques such as gel electrophoresis, capillary electrophoresis (Agilent Bioanalyzer 2100, Advanced Analytics Fragment Analyzer), qPCR, HPLC is desired
- Zero to two (0-2) years of relevant experience in manufacturing or laboratory research.
- Detail-oriented with strong written and verbal communication skills.
- Ability to work independently with minimal supervision, within prescribed guidelines, and as a team member.
- Ability to draft routine reports and keep accurate records of work performed.
- Actively seeks opportunities to increase skills and expertise.
- Able to learn complex task with general instructions and training.
- Able to perform a variety of new techniques.
- Demonstrated ability to follow detailed directions in a research laboratory environment.
- Must be familiar with Microsoft Office applications.
Senior Research Associate, Formulation Development
Senior Research Associate, Formulation Development will focus on supporting design, development, scale-up, manufacturing, and characterization of lipid nanoparticle based nucleic acid formulations to support an emerging research pipeline focused on treating rare diseases. Experience with nanoparticle production and purification processes including but not limited to tangential flow filtration (TFF – UF/DF) is highly desired.
The Senior Research Associate will be performing the following tasks under supervision:
- Design, development, and production of nucleic based formulations including complex nanoparticle formulations
- Process development, scale-up and technology transfer of multiple formulations, including supporting activities at CMO(s)
- Performing comprehensive operating range studies to understand formulation/ process limits and failure modes
- Performing formulation stability studies including but not limited to pilot stability studies with proposed drug product configuration, contact material compatibility and stability study, in-use compatibility study, accelerated stability studies, etc.
- Preparation and characterization of dose formulations for various in vitro and in vivo studies
- Perform process related investigations, identify root causes of process/manufacturing discrepancies, evaluate systems for trends and adverse findings, and implementing appropriate steps to ensure process robustness
- Maintain proper documentation of all experimental procedures and results, including batch records, protocols, Standard Operating Procedures (SOPs) and other manufacturing related documentation
- Prepare technical reports and presentations which summarize procedures, study results, and data interpretation as needed
- Deliver high quality results in an accurate and a time sensitive manner
- Perform other activities per supervisor’s direction
- Bachelor or MS (with 5-8+ years related industrial experience) in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, bioengineering or other industry-relevant fields.
- Experience with nucleic acid based formulations, complex/nanoparticle formulations, cleic acid based formulaiton,nfamiliar with these.sumbiutting?working knowledge of tangential flow filtration
- Hands on expertise working with liquid, frozen, and/or lyophilized dosage forms
- Preferred qualifications include but are not limited to familiarity with stages of drug product development and cGMP concept, knowledge of analytical methods for testing lipid nanoparticles and understanding of the in-vitro and in-vivo experiments used for screening of nanoparticle formulation.
- Must be highly motivated, well organized, an independent thinker with strong problem-solving skills, and pay great attention to details
- Comfortable working in a highly innovative and fast-pace environment and have a strong ability to cope with change
- Excellent verbal and written communication skills, great team player.
- Office/Lab environment. Lifting up to 50 pounds may be required. While performing the duties of this job, the employee is regularly required to use their hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as talk and hear. They are required to stand, walk or sit, reach with hands and arms, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.
We are currently seeking an Executive Assistant to join our fast-growing, dynamic and collaborative team.
The Executive Assistant will be primarily reporting to the CFO & CSO and other members of the executive team as needed, responsible for many facets of day to day support within the executive team and programs. The position requires extensive coordination and communication within Arcturus and with external board members, venture partners, and other outside parties, working with information that is of a critical and confidential nature. The role requires a high degree of initiative self-direction and collaboration, a high degree of tact and discretion, highly professional and corporate presence, self-confidence, flexibility, and adaptability. Ability to effectively work in a fast-paced changing corporate environment is critical to success in the position.
- Provide complex and diverse administrative duties for C-level executive(s), and business units.
- Manage calendars and assist in prioritization, time management, and maintaining deadlines.
- Coordinate a variety of internal and external meetings, conference calls, and web meetings across multiple time zones.
- Coordinate complex domestic and international travel plans, including monthly expense reporting and reimbursement.
- Screen incoming mail and telephone calls; take accurate messages, appropriate direct inquiries to other responsible parties in a timely and appropriate fashion.
- Handle information of a highly confidential and critical nature
- Work collaboratively with all members of the executive team and the Executive Assistant to the CEO to provide assistance as needed.
- Professional confidence in own ability during challenging circumstances and to demonstrate belief in one’s convictions. Demonstrated intuition as a result of experience working through complex situations/issues.
- Liaise with Arcturus board members, external partners, and investors
- Provide back up support to and work closely with other members of the administrative team, including providing coverage for vacations and absences as needed.
- Create and update complex PowerPoint presentations, as well as other documents and correspondence in Word and Excel.
- Facilitate, build and maintain executive level relationships.
- Other administrative tasks as assigned
- Proficiency with MS Office, including intermediate-advanced skills with Outlook, Word, Excel & PowerPoint.
- Ability to appropriately handle critical information and sensitive situations in a timely manner.
- Flexibility to handle a variety of tasks and shift priorities simultaneously.
- Self-motivated, enthusiastic and customer service oriented.
- Excellent organization and time management skills.
- Ability to remain calm under pressure and handle a variety of situations with peers and leaders in a professional manner.
- Ability to work effectively in a fast-paced organization
- Ability to effectively interact with all levels of staff and external contacts; ability to work as an effective team member.
- Strong level of initiative and ability to work with minimum supervision.
- BA/BS plus a minimum of 8 years related C-suite executive level administrative support experience in a corporate environment; or AS Degree plus a minimum of 10 years related C-suite executive level administrative support experience in a corporate environment
- Biotech environment highly desired
- Must have experience managing projects including the ability to multi-task
- A high level of organizational skills and attention to detail is required
- Must possess the ability to communicate written and orally in a clear & concise manner
- Ability to work in a fast-paced environment
Arcturus Therapeutics is seeking an innovative, highly motivated, experienced, resourceful, hands-on individual to join our expanding preclinical team in the role of Senior Scientist, Bioanalytical. The scientist will The successful candidate must have scientific knowledge and technical experience in developing, troubleshooting, transferring, optimizing, and validating PK, ADA, and Biomarker assays for biotherapeutics in biological matrices.
- The successful candidate must have scientific knowledge and technical experience in developing, troubleshooting, transferring, optimizing, and validating PK, ADA, and Biomarker assays for biotherapeutics in biological matrices.
- He/she must be able to design and oversee the execution of bioanalytical method development and validation studies using accepted industry methods with minimal guidance and supervision. The qualified candidate will be knowledgeable of current FDA and EMA GLP/GCP compliance as it relates to bioanalytical PK and ADA methods.
- The candidate is expected to manage outsourced bioanalytical projects and CROs to ensure high quality Bioanalytical data/reports are delivered in accordance with project timelines.
- Ph.D. in a relevant scientific discipline with at least 5+ years’ experience in bioanalytical assay development is a must.
- Experience in the design, implementation, and management of PK ADA, and Biomarker assay development in accordance with current industry standards for drug candidates in support of clinical stage programs.
- Experience in identifying and selecting high quality CROs for the conduct of clinical bioanalytical work.
- Able to successfully transfer and oversee qualification and validation of bioanalytical methods at CROs and oversee the subsequent analysis of clinical samples.
- Able to review and interpret bioanalytical data/reports in support of nonclinical safety studies and clinical trials.
- Effectively communicate with other departments within the organization, senior management, development teams, and CROs.
- Provide project summaries/reports in project team meetings.
- Experience in preparation of BA sections for regulatory (IND or foreign equivalent) filings is a plus.
- Excellent written and verbal communication skills, and ability to write technical reports.
- Excellent organizational skills, attention to detail and the ability to work independently and within a multi-disciplinary environment as well as with external vendors.
- The ability to prioritize and work in a fast-paced and diverse environment is required.
- Strong sense of urgency, initiative, ethics, integrity, and innovation is required
Senior Clinical Trial Manager
The Senior Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial ensuring deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role: external vendors (including bioanalytical and safety laboratories, drug depots, and full-service CROs. The position reports to the Chief Development Officer and is accountable to the Clinical Operations Lead for assigned studies. This role may work collaboratively on one trial or across several trials to support clinical operations activities.
- Day to day management of assigned clinical trial to ensure deliverables are met in all phases of trial
- Communication to internal team members on deliverables and ensuring timelines are met
- Manage trial feasibility process
- Work closely with study Clinical Operations Lead to execute clinical studies.
- Drafting or reviewing (if prepared by the CRO) site materials including training, manuals and support documentation.
- Monitoring of clinical data to ensure timely entry and readiness for data review meetings.
- Periodic review of clinical data
- Review of clinical monitoring reports to ensure timely completion and identification of issues
- Ensure laboratory samples are ready to be sent to vendors in order to meet trial deliverables; ensure all contracts are in place, and any required data transfer agreements are completed before any data transfers are needed
- Maintain trial metrics
- Ensure trial is conducted in accordance to Arcturus and ICH/GCP standards including multiple regions in global trials
- Support testing clinical trial systems/databases (i.e. UAT)
- Develop and maintain strong, collaborative relationships with key stakeholders within Arcturus
- Work collaboratively with all outside vendors and Arcturus consultants to achieve timelines; maintain a partnership with the primary CRO on each study to ensure all are working towards the same goals.
- Help prepare for and attend Clinical Advisory Board meetings
- Ability to interact effectively with Key Opinion Leaders
- Understand when issues need to be escalated to ensure timelines are met.
- 8 to 10 years of experience working in a clinical operations role (CRA, Clinical Trial Assistant); some experience working for a Sponsor preferred
- At least five years of trial management experience in a clinical research environment (Sponsor); early to mid-phase in both patients and healthy volunteers.
- Experience working on rare disease or vaccine studies (ideally Phase III experience in vaccine studies)
- Advanced degree preferred or Bachelor’s in a science-based subject
- Relevant experience in a global setting
- Solid understanding of drug development
- Good project management skills
- Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- Excellent verbal and written communication skills
- Good organizational skills and attention to detail
Accounts Payable Specialist (Biotech)
- Prepare general ledger entries by maintaining records and files, reconciling accounts.
- Reconcile and maintain equity, accounts payable and other accrual account reconciliations.
- Reconcile company credit cards on a monthly basis and organize all supporting documentation
- Develop and implement accounting procedures in the purchase to pay workflow by analyzing current procedures; recommending changes.
- Answer accounting and financial questions by researching and interpreting data.
- Perform the processing of monthly journal entry including accruals, amortization of prepaid expenses, and recording of adjusting and reclassification journal entries, if necessary.
- Assist the accounting supervisor with annual 1099’s.
- Prepare process memos as required.
- Well organized and timely.
- Life science industry experience a plus.
- Strong work ethic and eagerness to learn.
- Ability to work independently and be self-motivated.
- Strong collaborative skills and ability to work in a fast-paced environment.
- Experience with Microsoft Office Excel.
- This is a full-time, temp-to-hire opportunity.
Program Manager (Clinical – Vaccines)
This role is a key position within Arcturus’ Global Program Management Office and will be responsible for supporting the advancement of one or more clinical-stage programs. The successful candidate will be an experienced and self-motivated Program Manager responsible for the management of development timelines and deliverables with a clear understanding of functional interdependencies and critical path activities. The ideal candidate would be highly adaptable and proactive problem-solver who is highly knowledgeable of the processes involved in clinical studies.
- Collaborting with the functional leads (CMC, Regulatory, Quality and Clinical), develop cross-functional plans including realistic but aggressive timelines, budgets and resources planning, risk assessment and contingency planning.
- Tracking progress on the Programs against approved timelines, budgets, and resource allocations.
- Communicating Program status and issues to ensure milestones and deliverables are met.
- Managing Program team operations (planning agendas, scheduling meetings, preparing minutes, and following-up with team members on critical action, items) to advance the Program.
- Identifying and highlighting risks and issues within the Program(s) and escalating appropriately. Identifying, developing, and implementing effective mitigation and escalation strategies to address risks and issues.
- Maintain Team Framework (including templates and shared folder structure)
- Supporting management of vendors, CROs, CMOs, and consultants.
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
- Advanced degree in a scientific discipline with 5+ years, of supporting clinical stage programs in a pharmaceutical/biotechnology company
- Experience with vaccine development (required), ideally from discovery through licensure
- Superior understanding of financial planning and managing clinical program budgets, specifically for government funded programs (e.g. BARDA, CEPI) – required
- Demonstrates technical expertise in and understanding of cross-function clinical trials processes from study start-up through study closure (e.g., data management, safety, biostatistics, medical writing)
- Excellent attention to detail and accuracy in work with proven ability to work independently, with a high level of integrity on multiple tasks Strong work ethic, willing to put in the time and effort to complete critical tasks on time with quality
- Excellent sense of the urgency to deliver at/surpass study conduct targets
- Ability to support multiple project teams simultaneously, be well organized and have strong time management skills and attention to detail
- Ability to accommodate shifting priorities, demands and timelines
- Ability to work under limited supervision, determine personal work plan, schedule tasks and activities accordingly
- Ability to elicit cooperation from a wide variety of sources and to be persuasive, encouraging and motivating
- Experience at/or oversight of clinical research vendors (CROs, central imaging vendors, IXRS, etc.)
- Ability to establish and maintain effective working relationships with colleagues, vendors, and CROs
- Excellent knowledge and skill with Microsoft Office Software (Excel, Word, PowerPoint, and especially Microsoft Project)
Senior Research Associate/Scientist I, Translational Biology
Arcturus is seeking a highly motivated and skilled cell biologist with a proven track record of scientific accomplishment and technical expertise. This position requires an excellent ability to develop and optimize in vitro assays and troubleshoot technical challenges in an innovative and timely manner. Applicants should have extensive laboratory research experience and a desire to continue conducting experiments independently with a high level of vigor and quality
- Developing, optimizing and running cell-based assays to validate targets and mechanisms
- Protein quantification of in vivo samples
- Provide key data to project teams in a robust, reliable and timely fashion
- Prioritize and manage multiple research activities required for the successful execution of experiments integrated across different functional teams
- Contribute to written and oral presentations related to work being conducted for both internal and external presentation and publication
- Other duties as assigned
- PhD with 0-5 years post-graduate experience or MS degree with 5-8+ years related experience in cell biology, biology or biochemistry
- Previous experience in drug discovery, either in academic or industrial setting, is preferred but not required
- Proven hands-on experience with the development, optimization and execution of quantitative cell-based assays
- Excellent basic protein characterization skills e.g. Western blot, ELISA, quantification assays
- Excellent mammalian cell culture and transfection experience in BSL-2 setting
- Proficient in handling animal tissue and blood samples for protein and RNA quantification
- Exceptional team player with strong written and oral communications skills
- Demonstrated skills with MS Office (Excel, Word, PPT) and statistical analysis software (e.g., Prism).
- This is a full-time, temporary position.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters)
The Human Resources team manages the recruitment and employment process for Arcturus Therapeutics. To protect the interest of all parties involved, we will only accept resumes from a recruiter if an executed search agreement is in place at the start of the recruitment effort. Unsolicited resumes sent to Arcturus Therapeutics from recruiters do not constitute any type of relationship between the recruiter and Arcturus Therapeutics and do not obligate Arcturus Therapeutics to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.