Scope of the Role
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.

Key responsibilities include:
- 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

Required qualifications/skills:
- 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

If you're ready to drive rigorous, approval-focused CMC outcomes, we welcome your application.How Your Days Flow
Working fully remote on an Eastern schedule, you'll move between focused technical reviews and collaborative decision-making. Your day may start by aligning on late-stage priorities with CMC peers, then shift to reviewing control strategy elements and data packages that support readiness for validation and filing. You'll spend time translating emerging risks into practical options, clarifying what "good" looks like for documentation and traceability, and keeping stakeholders synchronized across time zones. As the day progresses, you'll track progress against interim milestones, prepare concise updates for governance forums, and close out by confirming next steps with partners so teams can execute efficiently and compliantly.Benefits at a Glance
Medical, dental, and vision coverage; 401(k); life insurance; Health Savings Account (HSA) and Flexible Spending Account (FSA) options; paid time off; employee discounts; and employer-paid short-term and long-term disability (STD & LTD). Competitive salary range: $158,000-$220,000 per year.