Director, Analytical Development

Arbor Biotechnologies•Cambridge, MA

2d•$220,000 - $240,000

About The Position

Arbor is seeking a Director, Analytical Development to lead phase-appropriate analytical strategy, method development, method transfer and analytical control strategy for AAV-based gene editing programs. This leader will be accountable for building and guiding analytical development capabilities that support progression from early development through clinical manufacturing, GMP readiness and regulatory submissions. The Director will serve as a technical and people leader, partnering closely with Process Development, Quality, Regulatory, and external testing laboratories to ensure robust analytical methods, high-quality data, and timely program advancement.

Requirements

Ph.D. or M.S. in biological sciences, biochemistry, analytical chemistry, pharmaceutical sciences, or a related discipline; advanced degree preferred.
10+ years of analytical development experience in biotechnology, biologics, vaccines, gene therapy, or a 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.

Nice To Haves

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, compatibility, 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.