Director, Analytical Development

Who we are.

Arbor Biotechnologies, a clinical stage, next-generation gene editing company based in Cambridge, MA, is advancing a portfolio of first-in-class genomic medicines addressing serious diseases for which there are no existing functional cures, with a CNS pipeline initially prioritizing multiple ALS targets and a co-developed, clinical program, ABO-101, for the treatment of primary hyperoxaluria type 1. The company’s unique breadth of gene editing technologies goes beyond the limitations of early editing approaches to unlock access to new gene targets and expand the therapeutic reach of genomic medicines.

For more information, please visit: arbor.bio.

Who you are.

You're driven by purpose and curious by nature. You take ownership, speak up, and stay steady when things get hard. You'd rather the team win than get the credit. If that sounds like you, keep reading.

About the Role. 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.

What you'll do.

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.

What you bring. 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…