Analytical Development and Quality Control 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:

Responsibilities

• Conduct routine analyses of in-process materials, drug substance, drug product and stability samples following written procedures. • Expand skill set of analytical technologies and test methods and assist in the development of test methods. • Participate as an analyst in qualification/validation of various biological and chemical QC assays. • Ability to perform aseptic technique and mammalian cell culture. • 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 testing 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 • Follow company, GxP and regulatory requirements, as applicable. • Supply QC data necessary for regulatory submissions. • May serve as a training mentor to new AD/QC personnel; serve as technical expert and liaison between AD/QC 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.

Analytical Development and Quality Control Associate II

The AD/QC Associate 2 will conduct analytical experiments that support manufacturing process development and research activities in a fast-paced, high-throughput laboratory setting. 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 Experience

• Expertise with one or more of following analytical techniques: SDS-PAGE, ELISA, qPCR, RT-qPCR, Western blots and cell-based potency assays • Advanced problem solving skills and high proficienty 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: jobs@arunabio.com Subject line: AD/QC Associate 2