Analytical Development Scientist

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:

Responsibilities

• Key role in product characterization, method development, product/process comparability, specification setting, stability strategy and critical quality attribute assessment. • Serve as a subject matter expert to provide technical guidance and assistance concerning new and existing methodologies. • Responsible for creating experimental plans and method development reports. • Perform data analysis, identify trends, and incorporate findings into development and control strategies. • Technical expert in identification and investigation of laboratory errors/OOS, perform root-cause analyses to determine the source of the error and recommend appropriate corrective and preventive actions. • Responsible for defining and justifying specifications, including specification refinement. • Evaluate and develop a diverse array of technologies and methods, including leading continuous improvement of existing methods. • Lead qualification/validation efforts for advanced biological/analytical methods according to applicable policies and guidelines. • Troubleshoot software or equipment malfunction to determine the source of error. • Subject matter expert in interpretation and application of relevant FDA/EU and ICH regulations and guidelines. • May author and review relevant CMC sections and data packages in support of regulatory submissions (e.g., IND, BLA) and interactions with Regulatory Agencies. • Perform occasional work outside of the normal business hours, including weekend work. • May supervise and mentor QC/AD personnel; serve as technical expert and liason between QC/AD and other departments, vendors or contractors. • Perform other appropriate duties as assigned by Management.

Analytical Development Scientist

The Analytical Development Scientist is responsible for developing and executing analytical strategy and development of comprehensive panels of tests for cell-derived, exosome products in collaboration with R&D team; position reports into a Director or Head of Unit. The AD Scientist will be a team lead for the work group and will work on highly complex technical and business matters.

Qualifications

• Proven expertise with broad knowledge of and extensive hands-on experience developing comprehensive panel of assays for biotherapeutics, including microbiological methods, cell-based assays, particle size analysis, flow cytometry, qPCR, ELISAs, bioactivity assays, etc. • Advanced problem solving skills and high proficiently with necessary data analysis and statistical methods. • Excellent written and oral communication skills. • Exceptional organizational and documentation skills, with high level of attention to detail. • Proven experience managing and presenting complex scientific data. • Excellent computer skills, including Microsoft Word, Excel and PowerPoint. • Proven ability to oversee operational aspects and manage multiple projects while meeting high priority deadlines. • Demonstrated productivity and professionalism while working in a team environment with ability to lead team efforts. Education: Typically requires a PhD in a biomedical science with a minimum of 3-5 years or Masters with 7-10 years or BS with 10-13 years of experience developing bioassays and analytical methods for biotechnology products. 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 Scientist