Director, Analytical Development for AAV Gene Therapy

Arbor Biotechnologies; Cambridge (MA); On-site; USD 220,000 - 240,000; Full time

Benefits offered by this job

Bonus and new hire equity

12 weeks parental leave

Paid parking or transit

401(k) match

Discretionary time off

Health premiums coverage (90%) and HSA

Job summary

Arbor Biotechnologies in Cambridge, MA, is seeking a Director of Analytical Development to lead strategy, method development, transfer, and control plans for AAV gene editing programs. You will partner with QC, Process Development, Regulatory, and external labs to ensure robust data and timely program progression.

The role requires a PhD or MS in a related field, 10+ years in analytical development, and a track record of guiding method validation and regulatory submissions for viral vectors.

Qualifications

• PhD or MS in biological sciences, biochemistry, analytical chemistry, pharmaceutical sciences or related field.
• 10+ years in analytical development in biotech or gene therapy, with AAV or viral vectors experience.
• Experience leading activities across development stages and GMP readiness.

Responsibilities

• Lead analytical development strategy and execution for AAV programs.
• Establish phase-appropriate analytical control strategies for IND enabling and clinical development.
• Mentor and manage an analytical development team and external testing partners.
• Author and review analytical sections of regulatory submissions and reports.

Skills

Analytical development

AAV

Viral vectors

Method transfer

Regulatory submissions

Leadership

CMC collaboration

Education

PhD or MS in biological sciences

Job description

Arbor Biotechnologies in Cambridge, MA, is seeking a Director of Analytical Development to lead strategy, method development, transfer, and control plans for AAV gene editing programs. You will partner with QC, Process Development, Regulatory, and external labs to ensure robust data and timely program progression.

The role requires a PhD or MS in a related field, 10+ years in analytical development, and a track record of guiding method validation and regulatory submissions for viral vectors.