Director, Analytical Development – AAV Gene Therapy

Arbor Biotechnologies; Cambridge (MA); On-site; USD 220,000 - 240,000; Full time

Benefits offered by this job

New hire equity

Annual bonus

Comprehensive health coverage

Discretionary paid time off

Job summary

Arbor Biotechnologies is seeking a Director of Analytical Development to lead phase-appropriate analytic strategy, method development, transfer, and control strategies for AAV-based programs. You will guide data quality, coordinate with Process Development, Quality, Regulatory, and external labs to ensure IND-enabling studies and regulatory readiness.

The role requires a strong scientific background, 10+ years in analytical development (AAV/viral vectors), and a track record of building

Qualifications

• Ph.D. or M.S. in biological sciences, biochemistry, analytical chemistry, pharmaceutical sciences, or related discipline.
• 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 the 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.

Responsibilities

• Lead analytical development strategy and execution for AAV-based gene editing programs, including method development, optimization, qualification, transfer, validation support, characterization, comparability, and stability-related testing.
• Establish and maintain phase-appropriate analytical control strategies that support IND-enabling studies, clinical development, GMP manufacturing and release, regulatory submissions, and product lifecycle needs.
• Provide strategic and technical direction for analytical method readiness, ensuring methods are fit for purpose, scientifically justified, and prepared for transfer, qualification, and validation at appropriate development stages.
• Lead development of phase-appropriate specifications, critical reagent strategies, reference standard characterization approaches, 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 phase-appropriate validation, assay performance monitoring, troubleshooting, and continuous improvement.
• Provide senior technical leadership for OOS/OOT investigations, deviations, assay remediation, comparability assessments, analytical risk assessments, and method lifecycle management.
• Author, review, and approve analytical sections of regulatory submissions, technical reports, protocols, control strategy documents, comparability packages, 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, regulatory discussions, and external partner interactions.
• Build, mentor, and develop a high-performing analytical development team, fostering scientific rigor, accountability, collaboration, technical excellence 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.

Skills

Analytical development leadership

Viral vectors

Cross-functional collaboration

Regulatory submissions

Mentoring and people development

Strategic planning

Education

Ph.D. in biological sciences

M.S. in biochemical/analytical chemistry

Job description

Arbor Biotechnologies is seeking a Director of Analytical Development to lead phase-appropriate analytic strategy, method development, transfer, and control strategies for AAV-based programs. You will guide data quality, coordinate with Process Development, Quality, Regulatory, and external labs to ensure IND-enabling studies and regulatory readiness.

The role requires a strong scientific background, 10+ years in analytical development (AAV/viral vectors), and a track record of building