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... Backed by Accel.
About the role
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. The anticipated base salary range for this role is $220,000–$240,000. Final offers depend on experience, skills, and other job-related factors. All employees are eligible for new hire equity, an annual bonus, comprehensive health coverage, and discretionary paid time off.
What they're looking for
- 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
- 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
More about this role
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...
Browse similar: Startup jobs