Aurora Biosynthetics · 18 hours ago
Process & Manufacturing Engineer
Boston, MA
Full-time
Onsite
Entry, Mid LevelAurora Biosynthetics is an advanced manufacturer of RNA-based products based in Sydney, Australia. They are seeking a dedicated Process & Manufacturing Engineer to develop robust manufacturing processes for startups and collaborate with established companies to optimize processes and ensure compliance with GMP standards.
BiotechnologyManufacturingMedical
Responsibilities
Support the development and optimisation of manufacturing processes for pDNA, mRNA, and LNP encapsulation
Draft and review protocols and Master Batch Records
Assist with chromatography, filtration, and purification troubleshooting
Collaborate cross-functionally to ensure end-to-end RNA process performance
Perform ENG and GMP manufacturing runs
Support IQ/OQ/PQ of RNA manufacturing and downstream purification equipment including chromatography and TFF systems
Participate in the execution and witnessing of validation protocols
Train other operators in the manufacturing process
Assist with cleaning and disinfection of equipment, materials, and facilities per GMP standards
Draft and review Standard Operating Procedures (SOPs) related to equipment use, maintenance, and validation
Ensure all documentation aligns with GMP standards and supports regulatory submissions
Qualification
Required
Bachelor's degree in Bioprocess Engineering, Chemical Engineering, or a related field
Experience with GMP regulations and quality systems such as deviations, CAPAs, change controls
Strong attention to detail and excellent organisational skills
Strong ability to work with in a multi-disciplinary environment and communicate with diverse stakeholders
Preferred
Preferred experience in a CDMO environment
Additional experience with RNA processes and single-use systems will be advantageous
Benefits
Unique opportunity to participate in the expansion of Australia’s biotech segment of cutting-edge therapies
Opportunity to contribute actively to the development of RNA manufacturing capability, serving domestic and global markets
Competitive compensation collaborative, entrepreneurial work environment with national and international significance
Company
Aurora Biosynthetics
Aurora Biosynthetics is an RNA manufacturing company that provides GMP plasmid DNA, GMP mRNA, LNP formulation, and fill-finish services.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase