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

Inc • Cambridge, MA

13h • Remote

About The Position

If you're passionate about gene therapy and its ability to enhance the lives of patients, then Beacon is a great team to join. We're a diverse, multi-national team of talented people all working together at our sites in the US and the UK, or as a remote contributor. Everyone here, whatever their role or location, plays a genuine part in bringing our treatments to patients. Everyone has a voice, and every contribution makes a difference. 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.

Requirements

• Proven late-stage biotherapeutic CMC leadership through process validation, regulatory submission/approval, and market launch
• Strong GMP knowledge and experience supporting GMP biomanufacturing execution

Nice To Haves

• HSV and AAV gene therapy production experience

Responsibilities

• 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

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed