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Salary: USD 220,000 - 240,000 / annual
Arbor Biotechnologies, a clinical-stage gene editing company based in Cambridge, MA, is seeking a Director of Analytical Development to lead analytical strategy, method development, and control strategy for AAV-based gene editing programs. This role combines technical leadership and people management, with accountability for building analytical development capabilities that support progression from early development through clinical manufacturing, GMP readiness, and regulatory submissions.
You will serve as both a technical and people leader, partnering closely with Process Development, Quality, Regulatory, and external testing laboratories. Key responsibilities include:
• Lead analytical development strategy and execution for AAV-based gene editing programs, including method development, optimization, qualification, transfer, validation support, characterization, comparability, and stability testing.
• Establish and maintain phase-appropriate analytical control strategies supporting IND-enabling studies, clinical development, GMP manufacturing, regulatory submissions, and product lifecycle needs.
• Provide strategic and technical direction for analytical method readiness, ensuring methods are fit for purpose and scientifically justified.
• Lead development of phase-appropriate specifications, critical reagent strategies, reference standard characterization, assay controls, and analytical comparability plans in partnership with Quality, Process Development, CMC, and Regulatory.
• Partner with QC and external laboratories to ensure successful method transfer, GMP validation, assay performance monitoring, troubleshooting, and continuous improvement.
• Provide senior technical leadership for OOS/OOT investigations, deviations, assay remediation, comparability assessments, and method lifecycle management.
• Author, review, and approve analytical sections of regulatory submissions, technical reports, protocols, control strategy documents, and CMC source documentation.
• Serve as the Analytical Development subject matter expert on cross-functional CMC and program teams, representing the function in governance forums and regulatory discussions.
• Build, mentor, and develop a high-performing analytical development team, fostering scientific rigor, accountability, collaboration, and compliance.
• Manage priorities, resources, timelines, and external testing partners to support program goals and ensure timely delivery of high-quality analytical data.
• Influence cross-functional decision-making by translating complex analytical data and technical risks into clear recommendations for program, manufacturing, quality, and regulatory strategy.
REQUIREMENTS:
• Ph.D. or M.S. in biological sciences, biochemistry, analytical chemistry, pharmaceutical sciences, or related discipline; advanced degree preferred.
• 10+ years of analytical development experience in biotechnology, biologics, vaccines, gene therapy, or related field, with significant experience supporting AAV or viral vector products.
• Demonstrated experience leading analytical development activities across multiple stages of development, including early development, IND-enabling work, clinical manufacturing support, method transfer, and GMP readiness.
• Strong technical expertise in developing, transferring, qualifying, and supporting validation of methods for viral vector characterization, release, device compatibility, comparability, and stability testing.
• Strong understanding of FDA, EMA, ICH, USP, and GMP expectations related to analytical development, method validation, QC implementation, reference standards, specifications, and lifecycle management.
• Proven ability to lead and develop scientists, manage external testing partners, and influence stakeholders across CMC, Quality, Regulatory, Manufacturing, and Research.
• Demonstrated ability to set analytical strategy, prioritize work across programs, manage technical risk, and drive timely execution in a dynamic development environment.
• Strong scientific judgment, technical problem-solving skills, and ability to balance long-range analytical strategy with hands-on technical leadership.
• Excellent communication skills, with ability to represent Analytical Development in governance, regulatory, technical, and external partner discussions.
• Experience supporting late-stage clinical development, analytical validation campaigns, GMP QC readiness, and regulatory submissions for AAV gene therapy products preferred.
