(Sr.) Process Engineer, MSAT - Downstream
About the position
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.
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.
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. Experience with antibody-drug conjugates (ADC) and drug conjugation is a plus.
• 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.
• Experience supporting process validation and PPQ campaigns preferred.
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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Apply To this Job
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.
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.
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. Experience with antibody-drug conjugates (ADC) and drug conjugation is a plus.
• 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.
• Experience supporting process validation and PPQ campaigns preferred.
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
Apply tot his job
Apply To this Job