Director, AAV Analytical Development & Strategy

Rippling, Inc.

Cambridge (MA)

On-site

USD 220,000 - 240,000

Full time

10 days ago

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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 strategies, method development, transfer, and analytical control for AAV-based programs. You will guide capabilities supporting early development through clinical manufacturing, GMP readiness, and regulatory submissions.

The role requires leadership, collaboration with QC/Regulatory, and strong expertise in viral vector method development and validation.

Qualifications

Ph.D. or MS in relevant biosciences; advanced degree preferred.
10+ years in analytical development in biotech/biologics/gene therapy with AAV experience.
Leadership across development stages and external partners.
Strong knowledge of FDA/EMA/ICH/USP/GMP expectations for analytical development.

Responsibilities

Lead analytical development strategy for AAV-based programs.
Establish phase-appropriate analytical control strategies for IND-enabling to GMP readiness.
Oversee method transfer, qualification, validation and comparability testing.
Collaborate with QC and external laboratories for method transfer and validation.
Lead investigations (OOS/OOT) and deviations; drive risk mitigations.
Author analytical sections of regulatory submissions and technical reports.
Mentor and develop the analytical development team.
Represent Analytical Development in governance, regulatory discussions, and partner interactions.