Process Development Associate III

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.

Key Responsibilities

• Set up, execute, and monitor experiments related to process development • Design and execute experiments associated with scale-up production processes • Troubleshoot experiment errors and perform root-cause analyses to determine the source of error • Provide technical guidance and assistance concerning process technique and equipment usage practices • Manage multiple projects simultaneously with minimal supervision • Maintain detailed records that are legible, accurate and readily understood following proper GxP recording • Works independently on specified tasks as defined by the Manager • Excellent communication skills and professional/technically proficient • May serve as a training mentor to new team members and on newly developed processes • Strong ability to analyze complex visual data in a quantitative and objective manner • Make decisions that impact a range of standard and non-standard operational, process, project activities within guidelines and policies • Serves as a key resource within a functional area or discipline • Gains support for ideas or positions on difficult issues • Proactively seeks to improve oneself and is recognized by peers and superiors as an emerging leader • Anticipates and solves complex problems • Influence and impact across functional teams • May lead medium-scale projects or programs with moderate risks and resource/financial requirements • May manage budgets for small to mid-sized projects • Communicates and plans research material needs, plans and coordinates supply orders, and handles non-standard requests • Must take the initiative as problems and/or opportunities arise • Perform occasional work outside normal business hours, including weekend work • Safe handling, storage, and maintenance of chemicals according to Environmental Safety Division and OSHA regulations

Process Development Associate III

The Process Development Associate will be responsible for supporting process development and optimization. Daily activities will focus on but not be limited to process parameter optimization, process characterization, scale-up for large scale biologic production. The position requires an individual skilled in the design and development of methods for biologic upstream cell culture and optimizing scaled manufacturing operations and collaborating across multiple functional teams. Demonstrated excellence in communication, the desire to learn and integrate multiple aspects of drug development in the rapidly evolving field of exosome biologics. The selected individual is expected to be a highly collaborative and driven by the desire to see the team succeed over one’s individual success. 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. We are looking for a proactive, resourceful, and goal-oriented team member with a translational mindset and a do-what-it-takes attitude, who will work effectively both independently and as part of a matrixed project team.

Professional Experience

• Understanding of biologics manufacturing is required in multiple areas. Knowledge and hands-on experience including cell culture development using bioreactors at varying scales • Experience with optimizing process parameters and supplementation to increase product yield and stability is strongly desired. Occasional effort may be needed in downstream purification. • Strong working knowledge of stem cell biology • Familiarity with technical transfer of complex upstream processes to ISO/CGMP large-scale operations • 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 • Demonstrated ability to work independently with limited supervision, demonstrating personal accountability • Demonstrated attention to detail and time management are essential along with strong written and verbal communication skills • Demonstrated excellent organization skills and ability to manage substantial amounts of technical data and documentation • Advanced ability to conduct literature searches on PubMed, Google Scholar, etc. • Proficiency with standard computer software as well as statistical software (JMP or GraphPad Prism) • Work experience within the Biotech/Pharma industry in a Process Development role is preferred • Excellent written and oral communication skills • Demonstrated ability to work productively in a team environment is necessary • Proven ability to multi-task and meet multiple high priority deadlines • Experience using Design of Experiments (DOE) and Quality by Design (QbD) methodologies• Education: BS degree required in relevant field with 5-6 years direct and/or relevant experience will be preferred or MS degree in relevant field with 2 years' experience desirable.
Qualified candidates submit a cover letter and resume to: Subject line: Process Development Associate III