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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.
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.

Associate Director/Director, Technical Operations and Development - REMOTE East Coast Based
Cambridge, MA, 02139, USPosted 2 weeks ago
Full-timeonsite
Job Description
Who We Are
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.
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.