Aura Biosciences

Director

• Lead the development of a new synthetic organic chemistry process, executed at external CDMO/CRO partners supporting the novel virus-like drug conjugate program
• Drive the design, review, approval and execution of external protocols and experiments
• Analyze external experimental data to drive synthetic experimental plans at CROs and CDMOs
• Provide chemistry-specific technical support to MSAT during scale-up of the synthetic process to a suitable manufacturing scale
• Support tech transfer of the scaled-up synthetic process from development to GMP
• Establish control strategies for process impurities and degradants
• Evaluate synthetic routes and recommend improvements to enhance process robustness, efficiency, safety, and scalability
• Provide scientific assessments of potential mutagenic impurities and other impurities of concern
• Define critical quality attributes and specifications
• Provide chemistry-specific input to support assessment of process changes and deviations during GMP manufacturing
• Author and review CMC sections of relevant regulatory submissions, including IND and NDA/BLA Module 3
• Lead scientific evaluation of regulatory starting material selection and justification
• Evaluate reagent, solvent, intermediate, and raw material considerations from a process chemistry perspective
• Collaborate with Analytical Development to define analytical method needs and support impurity characterization
• Contribute to process hazard and safety assessment for scale-up activities
• Work with cross-functional teams across Tech Ops, Quality, Regulatory, and CDMO partners to identify risks impacting program timelines

Associate Director, Synthetic Organic Chemist, MSAT

• Serve as the SVP, Quality's principal operational partner for Product Quality and CMC Quality matters
• Develop and execute Product Quality strategy from late-stage clinical development through BLA submission, approval, commercial launch, and lifecycle management
• Establish Product Quality priorities, governance, metrics, and organizational capabilities
• Provide strategic Quality input to company, portfolio, CMC, manufacturing, supply, and product development strategies
• Identify, assess, and escalate significant Quality risks and provide risk-based recommendations to senior leadership
• Provide senior Quality oversight across CMC, drug substance and drug product manufacturing, and product quality activities
• Lead Quality activities for manufacturing site selection, qualification, onboarding, technology transfer, site changes, process validation, continued process verification, analytical method transfer and validation, and commercial readiness
• Oversee specifications, control strategies, stability, deviations, investigations, CAPAs, changes, and product disposition
• Provide strategic oversight of analytical control strategies, release, in-process, stability, characterization, and other analytical testing
• Establish governance for specifications, sampling plans, reference standards, stability programs, and analytical lifecycle management
• Establish Quality governance and risk-based oversight for external manufacturing, testing, and supplier networks
• Provide executive-level oversight of CMOs, contract testing laboratories, critical material suppliers, and strategic partners
• Lead Product Quality readiness for BLA submission and commercialization
• Serve as a senior Quality representative during FDA and other health authority inspections and interactions
• Lead Product Quality inspection readiness across Aura and critical external partners
• Lead the Product Quality workstream for commercial readiness and launch
• Establish readiness plans, milestones, deliverables, and governance supporting BLA approval and commercial launch
• Establish the Product Quality framework for post-approval changes, complaints, investigations, CAPAs, product monitoring, and lifecycle management
• Establish and maintain a Product Quality Risk Management framework consistent with ICH Q9(R1)
• Develop proactive Quality metrics and risk indicators
• Build, lead, and develop a high-performing Product Quality organization
• Recruit, develop, mentor, and retain Quality professionals and leaders
• Serve as a senior Quality partner to Technical Operations, CMC, Regulatory Affairs, Supply Chain, Clinical Development, Medical Affairs, and other functions
• Represent Quality in key program governance and business planning forums

Executive Director – Product Quality

QA Engineer

• Develop and lead the GCP Quality strategy and quality framework supporting Aura Biosciences’ clinical development portfolio, focusing on pivotal and late-stage programs
• Establish and continuously improve a risk-based Clinical Quality Management System covering auditing, quality events, CAPA, issue management, training, vendor oversight, and continuous improvement
• Provide independent Quality leadership and strategic counsel to Clinical Operations, Clinical Development, Regulatory Affairs, and other GCP functions
• Establish GCP quality objectives, metrics, leading indicators, and strategic quality reporting
• Identify, assess, escalate, and remediate emerging compliance and quality risks
• Provide strategic Quality oversight of global CROs, investigators, vendors, and other external partners
• Establish risk-based qualification, oversight, monitoring, and performance assessment processes for GCP and GLP vendors
• Provide Quality input into clinical development strategies, protocols, informed consent forms, Clinical Study Reports, and other clinical documentation
• Lead risk-based GCP audits across clinical systems, processes, investigator sites, CROs, vendors, and computerized systems
• Oversee audit observations, inspection findings, CAPAs, remediation plans, root cause analysis, quality event management, and CAPA effectiveness
• Own and lead GCP Inspection Readiness strategy
• Lead preparation for and hosting of FDA BIMO and other global regulatory inspections
• Establish inspection readiness governance, training, mock inspections, BIMO interview preparation, document readiness, and response processes
• Serve as senior GCP Quality leader during regulatory inspections and direct inspection responses and remediation
• Represent Quality on clinical and cross-functional governance forums and advise senior management
• Build partnerships across Clinical Operations, Clinical Development, Regulatory Affairs, Medical Affairs, Data Management, Pharmacovigilance, and other functions
• Provide leadership, coaching, and development to GCP Quality personnel
• Establish the strategic approach for GCP training and compliance awareness
• Drive continuous improvement initiatives and support enterprise-wide Quality initiatives

Associate Director, Synthetic Organic Chemist, MSAT

Executive Director – Product Quality

Executive Director, Clinical Quality Assurance