Quality Control/ Analytical Development Associate IV

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 for our partners. Through this 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 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:

Key Responsibilities

• Performs various complex scientific analyses to evaluate the raw materials, in-process materials, and finished goods and ensure compliance with established standards. • Skilled in aseptic technique and performing mammalian cell culture. • Evaluate and develop new technologies and methods. • Develop and execute method qualification/validation protocols for various biological and chemical methods and ensuring compliance with applicable policies and guidelines. • Responsible for writing/revising/approving standard test methods, standard operating procedures and other documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms. • Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release. • Identification and investigation of laboratory errors and OOS, performs root-cause analyses to determine the source of the error and implements appropriate corrective and preventive actions. • Contributes to specification setting and justification, including recommending specification changes. • Ensure equipment is appropriately calibrated, qualified and maintained, and ensuring appropriate safety procedures are in place. • Provide technical guidance and assistance concerning use of equipment and performing laboratory procedures. • Troubleshoot software or equipment malfunction to determine the source of error. • Develop appropriate department procedures to comply with GxP and regulatory requirements. • Supply, compile and analyze QC data necessary for regulatory submissions. • Perform occasional work outside of the normal business hours, including weekend work and ensure appropriate staff scheduling. • Proactively work to identify and resolve problems before they arise. • Perform other appropriate duties as assigned by Management. • May supervise and guide the work of multiple QC staff; serve as technical liason between QC and other departments, vendors or contractors; coordinate and schedule internal testing and external testing with contract laboratories and vendors.

Quality Control/ Analytical Development Associate IV

The QC/AD Associate IV is responsible for supporting manufacturing and testing efforts, reporting into a Manager/Director, with work highly independent. The QC/AD Associate IV may assume a team lead role and supervisor for the work group and will work on complex technical and business matters. Activities include developing and validating complex methods and conducting complex testing on raw materials, process intermediates, drug substance, drug product and stability samples.

Experience and qualifications

• Expert in performing multiple biological/biochemical assays and extensive assay development experience in biological/biochemical assays such as gel electrophoresis, microbiological methods, cell-based assays, particle size analysis, flow cytometry, qPCR, and ELISAs. • Proficiency with data analysis and statistical methods including linear regression and ANOVA. • Excellent written and oral communication skills. • Exceptional organizational and documentation skills, with strict attention to detail. • Ability to write detailed instructions including standard test methods and method validation protocols and to write method validation and development reports. • Excellent computer skills, including Microsoft word, excel and powerpoint. • Proven ability to manage multiple projects while meeting high priority deadlines. • Demonstrated productivity and professionalism while working in a team environment and ability to coordinate activities across the team. • Ability to work independently with integrity and and take on supervisory responsibilities. Education and Experience: Typically requires a bachelor’s degree in a biomedical science with a minimum of 10+ years related experience or a Master’s degree with 8+ years related experience in a GMP environment, including 2+ years of supervisory experience. Preference will be given to candidates with experience performing, developing and validating analytical methods for cell-based or biological therapeutics.
Qualified candidates submit a cover letter and resume to: jobs@arunabio.com Subject line: QC/AD Associate IV