Quality Control Associate (Stability) Temporary

WHY WORK FOR ARCTURUS?

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a clinical-stage mRNA medicines and vaccines company with enabling technologies: (i) LUNAR lipid-mediated delivery, (ii) STARR mRNA Technology and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus' diverse pipeline of RNA therapeutic and vaccine candidates includes self-replicating mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat Ornithine Transcarbamylase (OTC) Deficiency, Cystic Fibrosis, Cardiovascular Disease along with partnered programs including Glycogen Storage Disease Type 3, Hepatitis B Virus, 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 (192 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., Duke-NUS, 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.

THE OPPORTUNITY

Arcturus Therapeutics seeks a highly motivated, hands-on individual to join our expanding Analytical Development/Quality Control team as a Quality Control Stability Associate- Temp.

In this role, the Stability Coordinator will interact with cross-functional teams and the CMO/CTL to establish and implement real-time stability studies, including, but not limited to, notification for stability sample pulling, planning for shipment at a third-party lab, and reviewing and summarizing the test results generated after each time point.

The successful candidate will possess strong technical skills and the ability to review and analyze data for out-of-trends, if any. The candidate is expected to manage multiple projects and communicate data/reports in accordance with Arcturus' timelines. This position will directly report to the Stability Associate Director/Stability Coordinator in the Quality Control/Analytical Development Department and collaborate with other functional groups within the organization.

WHAT YOU WILL CONTRIBUTE

• The individual will also be responsible for collaborating with stability studies to ensure the timely execution of timepoint testing per the requirements stated in each stability protocol.

• Participate in the planning and review of real-time stability design and/or protocol.

• Coordinate with CMO/CTL to finalize logistics for product stability study set-up and initiation.

• Organize shipment of samples for Arcturus managed third party lab for testing as described in the protocol.

• Own and participate in meetings related to stability initiation and transfer.

• Request, receive, and track the raw data, and report for completed time points.

• Review and organize product stability data and study reports.

• Notify quality management for out-of-specification or out-of-trends discovered during the review of stability results.

• Formatting and reviewing stability summary tables for accuracy and compliance with current cGMP and Arcturus SOP.

• Write/revise stability protocol, prepare technical reports and presentations that summarize stability study trends/results, and provide data interpretation.

• Enter stability data into electronic databases/SLIM software accurately and efficiently.

• Assist in analyzing stability data trends over time. Collaborate with team members to identify patterns, deviations, or anomalies requiring further investigation.

• Support in activities such as creating draft reports and summaries.

• Ensure the integrity and accuracy of stability data by adhering to established data entry procedures and quality standards. Verify data entries for completeness and correctness.

• Analyze, review, and interpret chemical and bioanalytical datasets.

• Perform other duties as assigned.

WHAT WE SEEK

• BS or MS in cellular and molecular biology, immunology, biochemistry, chemistry, or other relevant biological disciplines.

• 2-3 years of industry experience is preferred.

• Knowledge and understanding of ICH and WHO guidelines for stability testing.

• Solid understanding of cGMP (21 CFR 210, 211, etc.) and data integrity requirements appropriate to quality control.

• Expertise in reviewing data from multiple analytical techniques, such as CE, HPLC, LC-MS instrumentation, UV-Vis, Karl Fischer, fluorescent plate readers, osmometers, and viscometers.

• Experience with LNP or mRNA delivery systems and analytical techniques is a plus.

• Experience in data analysis with Excel, JMP statistical software, and working with LIMS software is a plus. Strong attention to detail and a high level of accuracy in data entry tasks.

• Familiarity with the requirement of phase-appropriate qualification and validation of analytical procedures.

• Ability to think critically and creatively, pay close attention to details, and work independently; ability to determine appropriate resources for ongoing stability studies.

• Comfortable working in a highly innovative environment and having a strong ability to cope with change.

• Self-starter with the ability to take the initiative and drive processes.

• Excellent written and verbal communication skills, and proven ability to manage multiple experiments.

• Excellent organizational skills, attention to details, and proven ability to work under minimal supervision within a multi-disciplinary environment.

• EDUCATION

• BS/MS degree in cellular and molecular biology, biochemistry, biological sciences, pharmaceutical sciences, chemistry, or other relevant disciplines.

WHAT WE OFFER

An exciting opportunity to join a company that offers a competitive total rewards package that includes:

• Catered lunches

• Free variety of snacks and beverages

• Health and Wellness programs

• On Campus Gym

• Company sponsored FUN events

For a deeper dive into our company and corporate culture visit www.ArcturusRx.com