Director of Analytical Development, AAV Gene Therapy

Rippling, Inc.

Cambridge (MA)

On-site

USD 220,000 - 240,000

Full time

2 days ago
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Benefits offered by this job

Equity
Annual bonus
Health insurance
Discretionary time off

Job summary

Arbor Biotechnologies, a Cambridge-based clinical-stage gene editing company, seeks a Director, Analytical Development to lead phase-appropriate analytical strategy and method development across AAV programs, ensuring robust control strategies from early development through regulatory submissions.

You will mentor a high-performing team, collaborate with Quality, Regulatory, and external labs, and guide method transfer, validation, and lifecycle management to support GMP readiness and clinical

Qualifications

  • Strong leadership in analytical development across multiple development stages.
  • Excellent communication and collaboration with QA, Regulatory, and external labs.
  • Expertise in developing and transferring analytical methods for viral vectors (AAV).

Responsibilities

  • Lead analytical development strategy for AAV-based programs.
  • Establish phase-appropriate analytical control strategies for IND-enabling and clinical stages.
  • Oversee method transfer, qualification, validation, and comparability testing.
  • Support regulatory submissions with analytical sections and data packages.
  • Mentor and develop the analytical development team.

Skills

Leadership
Cross-functional collaboration
Analytical method development
Regulatory readiness

Education

PhD in biological sciences or related
MS in related discipline

Job description

Arbor Biotechnologies, a Cambridge-based clinical-stage gene editing company, seeks a Director, Analytical Development to lead phase-appropriate analytical strategy and method development across AAV programs, ensuring robust control strategies from early development through regulatory submissions.

You will mentor a high-performing team, collaborate with Quality, Regulatory, and external labs, and guide method transfer, validation, and lifecycle management to support GMP readiness and clinical

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