Aruna Bio is a clinical-stage biotech company advancing a new class of cell-free biologics — exosomes — for the treatment of central nervous system and neurodegenerative disorders. We're looking for a Bioprocess Associate 2 – Downstream to join our manufacturing team and support production of AB126, our lead therapeutic exosome candidate.
As a Downstream Bioprocess Associate 2, you'll be executing established bioprocess workflows and purifications in a cGMP environment, as well as contributing to the planning and procurement for future productions/purifications. We need someone with solid hands-on lab skills, disciplined documentation habits, and the ability to work both independently and in a group, within defined protocols.
Core Responsibilities:
- Perform downstream bioprocess workflows, including TFF systems, chromatography, and fill-finish, per established protocols and cGMP standards
- Support and occasionally participate in upstream bioprocess workflows via basic supply preparations, formulations, and documentation for mammalian cell culture
- Operate production equipment (pipettors, balances, biosafety cabinets, incubators, autoclaves, microscopes, centrifuges) accurately and safely
- Complete manual, cGDP-compliant documentation in batch records and forms with a high degree of accuracy
- Coordinate downstream supply needs (e.g. equipment and consumables sourcing/pricing) and assist with planning for future purifications
- Analyze downstream performance and production data and help generate reports.
- Collaborate with Process Development Team on technical transfer and experiment needs
- Contribute to the editing/updating of controlled process documentation as needed
- Mentor, train, and review the work and documentation of junior team members as needed
Required Skills and Experience:
- Bachelor's degree in a relevant field (e.g. bioprocessing, chemistry, biology) with 3+ years of directly relevant experience; or a master's degree with 1+ years of relevant experience; or an associate degree with a minimum of 5 years of relevant experience
- Previous professional experience with pilot or production-scale TFF purification and/or chromatography
- Excellent organizational and communication skills, and the ability to manage substantial technical data, multiple priorities, and competing deadlines
- Strong attention to detail and document review skills to reliably produce audit-ready process documentation
- Proficiency with primary Microsoft Office Suite tools (Outlook, Microsoft Word, PowerPoint, Excel)
- Ability to work cooperatively in a controlled environment (ISO 5, 7, and 8) wearing clean room PPE for extended periods of time
- Willingness to participate in a rotating weekend work and holiday schedule to perform primary cell culture maintenance processes
Preferred:
- Hands-on industrial experience in a cGMP-compliant environment
- Previous experience leading and operating commercial-scale FPLC, TFF, and other purification technologies
- Proficiency with statistical analysis tools (e.g. JMP, Prism)
- Working knowledge of downstream production principles specific to cell-free biologics
Pay: $66,964.92 - $72,970.49 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Education:
Work Location: In person
