Aura Biosciences

Executive Assistant

• Manage multiple Executives’ calendars, meetings, and schedules, resolving scheduling conflicts as they arise and prioritizing issues to ensure effective time management
• Communicate agendas and respond to calendar changes as needed
• Coordinate detailed domestic and international travel arrangements for team members including air, hotel, car, etc. as business travel needs dictate
• Complete expense reports and credit card reconciliation using Concur
• Coordinate logistics of special events including team meetings, conferences, seminars, workshops, off-site meetings, special projects, and department outings/team building
• Communicate with internal and external stakeholders with professionalism, accuracy, and speed
• Facilitate communication from team members by soliciting information from the team, providing critical updates, anticipating questions, and organizing priorities
• Demonstrated experience utilizing interpersonal and collaborative skills
• Prepare documents for Executives’ signatures and maintain an organized filing system
• Take initiative to problem solve and troubleshoot issues
• Apply a thorough knowledge of company operations and policies and procedures on a daily basis

Engineer

• 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.

Senior Process Engineer, MSAT - Downstream

• Lead and support tech transfer of cell culture and harvest processes to and within external partners, including gap assessments and readiness evaluations.
• Serve as upstream technical SME during engineering runs, GMP campaigns, and PPQ execution.
• Act as Person-in-Plant (PIP) at CDMOs providing front-line technical oversight.
• Drive resolution of manufacturing deviations, investigations, and change controls related to upstream unit operations.
• Collaborate cross-functionally with PD, AD, QA, QC, Supply Chain and Regulatory teams to ensure alignment through tech transfer and lifecycle management.
• Support development and execution of control strategies, risk assessments (FMEA), and continued process verification.
• Review and approve batch records, SOPs, and technical documentation.
• Analyze process performance data using statistical tools to monitor robustness and identify improvement opportunities.
• Support authoring and review of CMC sections related to upstream manufacturing for regulatory filings.
• Contribute to process scalability strategies and manufacturing readiness for commercial launch.

Senior Process Engineer, MSAT – Upstream

Director

• Lead analytical method activities to CDMOs, including transfer as appropriate, validation and authoring validation protocols and reports.
• Manage and review work performed under method validation protocols, method performance, and any required third party activities.
• Provide on-site technical readiness support and serve as SME during validation campaigns.
• Troubleshoot and resolve technical challenges related to method life cycle management and validation in partnership with CDMO and internal stakeholders.
• Drive continuous improvement and lessons learned initiatives across Aura and vendor sites.
• Monitor and trend analytical method performance in collaboration with Analytical Development (AD).
• Support quality systems activities, including change controls, deviation investigations, CAPAs, OOS investigations, and method improvements.
• Perform statistical analyses to support method validation, qualification studies, and critical material qualification.
• Ensure system suitability and ongoing method performance monitoring.
• Author and review GMP documentation, including:
• Method transfer protocols and reports, as required
• Validation protocols and reports
• Test methods and best-practice documents
• Maintain comprehensive documentation of validation and transfer activities.
• Contribute technical content to global regulatory filings supporting clinical development.
• Partner closely with Analytical Development, MS&T, Quality Assurance, and external testing laboratories.
• Lead training for new analytical methods at external labs and support QC analysts in execution, data analysis, and technical review.
• Present analytical findings and critical issues to cross-functional teams and leadership.

Senior Manager/Associate Director QC Scientist – Analytical, Late Stage Development, Process Excellence

• Lead analytical method activities to CDMOs, including transfer as appropriate, validation and authoring validation protocols and reports.
• Manage and review work performed under method validation protocols, method performance, and any required third party activities.
• Provide on-site technical readiness support and serve as SME during validation campaigns.
• Troubleshoot and resolve technical challenges related to method life cycle management and validation in partnership with CDMO and internal stakeholders.
• Drive continuous improvement and lessons learned initiatives across Aura and vendor sites.
• Monitor and trend analytical method performance in collaboration with Analytical Development (AD).
• Support quality systems activities, including change controls, deviation investigations, CAPAs, OOS investigations, and method improvements.
• Author and review GMP documentation, including: Method transfer protocols and reports, as required; Validation protocols and reports; Test methods and best-practice documents.

Senior Manager/Associate Director, QC Scientist – Cell Based Assays, ELISA – Late Stage Development & Process Excellence

Project Manager

• Provide leadership to cross-functional teams in the oversight, design and execution of process and analytical validations, technology transfers, and operations within CDMOs
• Lead, track and maintain CMC budget for CDMOs
• Manage cross-functional project CMC sub-teams for multiple development programs
• Build and maintain strong positive working relationships with CDMOs
• Develop, organize, and maintain dashboards, timelines, project plans and present information to CMC team and stakeholders
• Identify, track and escalate project risks to senior stakeholders

Executive Assistant

Senior Process Engineer, MSAT - Downstream

Senior Process Engineer, MSAT – Upstream

Senior Manager/Associate Director QC Scientist – Analytical, Late Stage Development, Process Excellence

Senior Manager/Associate Director, QC Scientist – Cell Based Assays, ELISA – Late Stage Development & Process Excellence

Director, CMC Project Management