Associate Director/Director, Technical Operations and Development

Role Description

As Associate Director/Director, Technical Operations and Development, you will steer late-stage CMC execution for gene therapy programs, ensuring development and manufacturing activities are aligned with global regulatory expectations from Phase III through validation, submission, approval, and launch.

• Lead cross-functional CMC planning across DP/DS, analytics, and MSAT, with clear milestones and progress reporting
• Define and implement analytical and manufacturing control strategies, including CQAs, CPPs, and specification/range setting
• Provide technical leadership to resolve complex testing, processing, and manufacturing challenges in regulated environments
• Partner with internal and external stakeholders to maintain alignment between program strategy and CMC deliverables

Qualifications

• Proven late-stage biotherapeutic CMC leadership through process validation, regulatory submission/approval, and market launch
• Strong GMP knowledge and experience supporting GMP biomanufacturing execution
• Highly desirable: HSV and AAV gene therapy production experience

Requirements

If you’re ready to drive rigorous, approval-focused CMC outcomes, we welcome your application.

Benefits

• Medical, dental, and vision coverage
• 401(k)
• Life insurance
• Health Savings Account (HSA) and Flexible Spending Account (FSA) options
• Paid time off
• Employee discounts
• Employer-paid short-term and long-term disability (STD & LTD)
• Competitive salary range: $158,000–$220,000 per year