(Sr.) Process Engineer, MSAT - Downstream
About The Position
Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is currently in late-stage development for primary choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura Biosciences is headquartered in Boston, MA. Our mission is to grow as an innovative global oncology company that positively transforms the lives of patients. For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn. Position Summary: Aura Biosciences is seeking a (Sr.) Process Engineer, MSAT - Downstream to support external drug substance purification and bulk manufacturing activities across clinical and commercial programs. Reporting to the MSAT Lead, External Manufacturing, this role will focus heavily on technology transfer, purification process performance, engineering execution, and PPQ readiness at CDMOs. This individual will serve as the technical SME for downstream unit operations including clarification, chromatography, filtration, concentration/diafiltration, and bulk drug substance handling. The candidate will act as Person-in-Plant (PIP) during GMP campaigns to ensure process robustness, data integrity, and successful batch disposition. This role requires strong technical depth in biologics purification and demonstrated experience navigating cross-functional GMP manufacturing environments.
Requirements
- B.S. or M.S. in Chemical Engineering, Bioprocess Engineering, Biotechnology, or related field.
- 4+ years (Process Engineer) or 6–8+ years (Senior Process Engineer) in biologics downstream manufacturing.
- Direct experience with chromatography systems, filtration platforms, TFF, UF/DF, clarification, or purification of complex biologics.
- Demonstrated experience supporting tech transfer and GMP manufacturing at CDMOs.
- Strong understanding of cGMP requirements and regulatory expectations.
- Experience supporting process validation and PPQ campaigns preferred.
- Strong problem-solving skills and data-driven mindset.
- Excellent communication and cross-functional collaboration skills.
- 20–30% travel anticipated.
Nice To Haves
- Experience with antibody-drug conjugates (ADC) and drug conjugation is a plus.
Responsibilities
- Lead and support tech transfer of downstream purification processes to and within external partners, as part of a broader effort to ensure robust and scalable supply.
- Execute and oversee downstream engineering runs and PPQ campaigns.
- Serve as Person-in-Plant (PIP) during GMP manufacturing operations.
- Provide technical leadership during investigations, deviations, and process excursions.
- Drive alignment between Process Development and Manufacturing to ensure successful scale-up and execution.
- Review batch records, SOPs, and technical reports to ensure manufacturing readiness.
- Develop and implement risk mitigation strategies and control plans for purification processes.
- Analyze process performance metrics including yield, impurity clearance, and product quality attributes.
- Collaborate with AD and QC teams on method validation and characterization strategies
- Support preparation and review of CMC regulatory documentation related to downstream manufacturing.
- Contribute to process robustness and lifecycle management strategies for commercial readiness.
Benefits
- Health insurance with FULL premium coverage
- 401K with company match
- Employee Stock Purchase Program (ESPP)
- Competitive paid time off (PTO)
- Company-paid short & long-term disability insurance and life insurance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
