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
• Ensure that lab upkeep and safety standards are maintained.
• Provide technical guidance and assistance concerning use of equipment and performing laboratory procedures. • Skilled in aseptic technique and mammalian cell culture.
• Responsible for writing standard test methods, standard operating procedures and other documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.
• Performs various routine analyses to evaluate the raw materials, in-process materials, and finished goods and ensure compliance with established standards.
• Compiles, interprets and documents statistical data from testing processes to either confirm compliance with established quality standards or identify deviations.
• Identification and investigation of laboratory errors and OOS, participate in root-cause analyses to determine the source of the error and recommend appropriate corrective and preventive actions.
• Evaluate new technologies and methods to make recommendations regarding their use.
• Develop and execute method qualification/validation protocols for various biological and chemical methods according to applicable policies and guidelines.
• Troubleshoot software or equipment malfunction to determine the source of error.
• Follow company, GxP and regulatory requirements, as applicable.
• Supply and compile QC data necessary for regulatory submissions.
• Perform occasional work outside of the normal business hours, including weekend work.
• Take initiative as problems and/or opportunities arise.
• Perform other appropriate duties as assigned by Supervisor or Management.
Quality Control/Analytical Development Associate II
The QC/AD Associate II is responsible for supporting manufacturing and testing efforts, reporting into a QC supervisor or manager, with work occasionally directed. The QC/AD Associate II will gain exposure to some of the complex tasks within the job function. Activities include developing and validating methods and conducting testing on raw materials, process intermediates, drug substance, drug product and stability samples.
• Proficient in laboratory analyses and knowledge of chemical and biological safety procedures. • Ability to perform multiple biological/biochemical assays such as gel electrophoresis, microbiological methods, cell-based assays, particle size analysis, flow cytometry, qPCR, and ELISAs and assisting in method development. • 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 follow and write detailed procedures including standard test methods and method validation protocols with limited oversight. • Excellent computer skills, including Microsoft word, excel and powerpoint. • Proven ability to manage multiple projects while meeting high priority deadlines with limited oversight. • Demonstrated productivity and professionalism while working in a team environment. • Ability to work independently with integrity and with limited supervision. Education and Experience: Typically requires a bachelor’s degree in a biomedical science with a minimum of 4 years related experience performing/developing/validating bioassays and analytical methods. 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: firstname.lastname@example.org Subject line: QC/AD Associate II