Engineer responsible for the design and modeling of Wagabox solutions to convert waste methane into renewable natural gas. Collaborating with engineering firms and ensuring compliance with North American standards.
About the role
- Senior Process Engineer supporting drug substance purification and bulk manufacturing activities at Aura Biosciences. Focus on technology transfer and process performance in a clinical-stage biotech setting.
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.
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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