Process Development Associate II

Aruna Bio is advancing a new class of cell-free biologics, exosomes, for the treatment of central nervous system (CNS) and neurodegenerative disorders and leveraging our novel platform to optimize the delivery of RNAs, antibodies, genes, and small molecules. Through this platform, we strive to improve outcomes for neurodegenerative, genetic, and rare diseases. If you are energetic, highly motivated, and want to work in a fast-paced, team-focused environment, then Aruna Bio wants to hear from you. The company is currently seeking to fill the following position:


• Set up and execute experiments related to process development • Set up and execute experiments associated with scale-up production processes • Troubleshoot experiment errors and assist in root-cause analyses to determine the source of error • Perform data analysis, identify trends, and incorporate findings into development and control strategies. • Manage multiple projects simultaneously with minimal supervision • Troubleshoot software or equipment malfunction to determine the source of error. • Ability to use a variety of equipment such as pipettors, balances, laminar flow hoods, incubators, autoclaves, microscopes, centrifuges, plate readers, and particle analyzer. • Maintain detailed records that are legible, accurate and readily understood. • Complete documentation needed to support development procedures including data capture forms, equipment logbooks, or inventory forms. • Compile laboratory test data and perform appropriate analyses. • Report questionable test results and participate in OOS and failure investigations. • Excellent communication skills and professional/technically proficient • Must take the initiative as problems and/or opportunities arise • May serve as a training mentor to new process development personnel; serve as technical resource and liaison between process development and other departments, vendors or contractors • Ensure that lab upkeep and safety standards are maintained. • Safe handling, storage, and maintenance of chemicals according to Environmental Safety Division and OSHA regulations • Perform occasional work outside of the normal business hours, including weekend work. • Perform other appropriate duties as assigned by Supervisor or Management.

Process Development Associate II

The Process Development Associate 2 supports biological product process development and optimization. Daily activities will focus on but not be limited to process parameter optimization, process characterization, scale-up for large scale biologic production. This position requires an associate who demonstrates excellence as a member of a highly collaborative team and who has a proven ability to execute and prioritize multiple experiments in parallel. The selected individual is expected to be a highly collaborative individual who is driven by the desire to see the team succeed over individual success. We are looking for a proactive, resourceful, and goal-oriented team member with a translational mindset and a do-what-it-takes attitude and who will work effectively independently and as part of a matrixed project team. Demonstrated excellence in communication, the desire to learn and integrate multiple aspects of drug development in the rapidly evolving field of exosome biologics.

Qualifications, Education, and Education

• Understanding of biologics manufacturing is required in multiple areas. Knowledge and hands-on experience including cell culture development using bioreactors at varying scales • Experience with optimizing process parameters and supplementation to increase product yield and stability is strongly desired. Occasional effort may be needed in downstream purification. • Strong working knowledge of stem cell biology • Familiarity with technical transfer of complex upstream processes to ISO/CGMP large-scale operations • Advanced problem-solving skills and high proficiency with necessary data analysis and statistical methods. • Proven experience managing and presenting complex scientific data. • Ability to work in laboratory setting with knowledge of basic chemical and biological safety procedures • Demonstrated excellent organization skills and ability to manage substantial amounts of technical data and documentation • Demonstrated attention to detail and time management are essential along with strong written and verbal communication skills • Demonstrated ability to work independently with limited supervision, demonstrating personal accountability • Good computer skills, including Microsoft word, Excel and PowerPoint. • Ability to handle multiple tasks concurrently and in a timely fashion • Demonstrated ability to work productively in a team environment is necessary Education and Experience: BS degree required in relevant field with 2-4 years direct and/or relevant experience will be preferred or MS degree in relevant field with 0-2 years' experience desirable. Preference will be given to candidates with experience developing methods for cell-based or biological therapeutics, especially lipid nanoparticles or extracellular vesicles.
Qualified candidates submit a cover letter and resume to: Subject line: Process Development Associate 2