Associate Scientist III, Analytical Development

Immunomic Therapeutics, Inc. (ITI) an HLB Company, is a privately-held, clinical-stage biotechnology company pioneering the development of vaccines through its proprietary technology platform UNITE®, which is designed to utilize the body’s natural biochemistry to develop vaccines that generate broad immune responses. ITI is primarily focused on applying the UNITE® platform to oncology indications, where it could potentially have broad applications, including development of antigen-derived antibodies as biologics in several cancers. The company has built a pipeline leveraging UNITE® with programs in oncology, animal health, infectious disease, and allergy.

The Analytical Development Scientist will contribute to the development of nucleic acid platform processes and analytical characterization of candidate drug molecules. The position will work in a multidisciplinary environment to advance ITI’s mission of building immune oncology/allergy/infectious disease vaccines. The main responsibility of the role involves hands-on work in a laboratory setting. A strong background in analytical methods is required for nucleic acid (DNA, RNA) drug substance and Lipid Nanoparticle Drug Product. Reporting to the Sr. Scientist, the Analytical Development Scientist will work closely with the Leadership, R&D scientists, and Quality Assurance.

• Develop and execute analytical assays for nucleic acid (DNA, RNA) drug substance and Lipid Nanoparticle (LNP) Drug Product characterization to support process development and pre-clinical studies.
• Perform required phase-appropriate qualification of analytical assays required to support the release of Toxicology (Tox) and clinical trial materials.
• Develop, optimize, and execute analytical assays to determine the storage, accelerated, and in-use stability of drug substance and drug product. Work with the Quality Assurance team to achieve compliance standards.
• Prepare data summaries, compile data, and author technical reports for use in regulatory submission.
• Communicate effectively with scientists, project managers, colleagues, and external vendors across various functions.

• Customer Focus
• Communication/Presentation Skills (spoken, written)
• Integrity/Ethics
• Initiative
• Sense of Urgency
• Teamwork
• Collaboration Skills
• Innovation

• BS +8, MS +5 years’ experience in analytical development for large molecules (industry experience required).
• Experience in analytical method development for nucleic acids is highly desirable.
• Proven ability to prepare precise technical summaries, protocols, SOPs, study reports and maintenance of appropriate documentation.
• Demonstrated ability in critical thinking, supporting R&D work with a focus on translational aspects of vaccine development.
• Excellent communication and people skills, ability to contribute individually and work well in a multi-disciplinary team environment.
• Excellent presentation and oral and written communication skills.
• Ability to prioritize and work in a fast-paced and diverse environment.
• Keen sense of urgency, initiative, ethics/integrity, and innovation is required.
• Prior experience with regulatory aspects and process development of drug discovery is desirable.

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.

Please visit our careers site at http://www.immunomix.com/careers/. Send your cover letter and credentials as described on the Careers page along with the Job Code: 2025 RD012 in the subject line.

Salary range for this position: $95-$115K

Equal Opportunity Employer