Project Engineer Intern assisting with various construction project tasks in Boston, MA. Engaging in scheduling, estimating, and quality control within the PECD program.
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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