Quality Control / Analytical Development Associate I

Aruna Bio is advancing an exciting new class of cell-free biologics, proprietary neural exosomes, for the treatment of central nervous system (CNS) and neurodegenerative disorders. Our neural exosome platform is also being leveraged for the delivery of RNAs, antibodies, genes, and small molecules. Through our exosome platform and our partners, we strive to improve outcomes for CNS, neurodegenerative, genetic, and rare diseases. Aruna Bio currently offers a wide range of full-time employee benefits that include: • Medical/Dental/Vision insurance options • Generous Paid Time Off • Generous Holiday calendar • Employee retirement plan • Employee training and professional development opportunities

Responsibilities

• Conduct routine analyses of raw materials, environmental samples, in-process materials, drug substance, drug product and stability samples following written procedures. • Ability to use a variety of equipment such as pipettors, balances, laminar flow hoods, incubators, electrophoresis, microscopes, centrifuges, plate readers, and particle analyzer. • Ability to perform aseptic technique and mammalian cell culture. • Participate as an analyst in qualification/validation of various biological and chemical QC assays. • Assist in the development of test methods. • Ensure that lab upkeep and safety standards are maintained. • 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. • Assist with troubleshooting of software or equipment malfunction to determine the source of error. • Follow company, GxP and regulatory requirements, as applicable. • Supply QC data necessary for regulatory submissions. • Perform occasional work outside of the normal business hours, including weekend work. • Perform other appropriate duties as assigned by Supervisor or Management.

Quality Control / Analytical Development Associate I

We are looking for an energetic, highly motivated individual who wants to work in a fast-paced, team-focused environment, within our Quality and Analytical Development Group. This individual will perform testing to support manufacturing, development and characterization efforts for our exosome products, reporting into a QC supervisor or manager. Activities include conducting a variety of cellular, molecular biology and analytical tests on raw materials, process intermediates, drug substance, drug product and stability samples.

Qualifications

• Ability to work in laboratory setting with knowledge of basic chemical and biological safety procedures • Excellent written and oral communication skills • Excellent organizational and documentation skills, with strict attention to detail • Ability to follow detailed written procedures with limited supervision • Good computer skills, including Microsoft word, excel and powerpoint. • Ability to handle multiple tasks concurrently and in a timely fashion • Ability to work collaboratively in a team environment Typically requires a bachelor’s degree in a biomedical science with 0-2 years related experience performing bioassays, molecular biology and/or analytical methods. Preference will be given to candidates with experience performing analytical methods for cell-based or biological therapeutics.
Qualified candidates should submit their cover letter and resume to jobs@arunabio.com with the subject line: QCAD Associate I