Associate Director/Director, Technical Operations and Development - REMOTE East Coast Based

Scope of the Role

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

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
• Employer-paid short-term and long-term disability (STD & LTD)

Pay

Competitive salary range: $158,000–$220,000 per year.

Schedule

Working fully remote on an Eastern schedule.