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Executive Director, Technical Operations and Development – REMOTE East Coast Based

MA, US

Cambridge

Posted 1 month ago

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 Executive Director, Technical Operations and Development, you will strengthen CMC execution for late-stage gene therapy programs, ensuring activities land on schedule, issues are driven to closure, and stakeholders remain aligned across internal teams and external partners.

Key responsibilities:
– Provide cross-functional technical leadership spanning viral vector production, analytics, quality, regulatory, and supply
– Guide late-stage submission and launch readiness, translating strategy into executable CMC plans
– Build and mature commercial supply chain capabilities (secondary packaging; 3PL/4PL models)
– Develop and maintain CMC guidance and decision frameworks; mentor and manage senior CMC leaders (direct/indirect)
– Navigate complex technical and organizational challenges with clear, influential communication

Required qualifications/skills:
– Multi-disciplinary late-stage submission/launch experience in biopharma, preferably gene therapies
– Strong CMC fundamentals (CQAs, CPPs) and strategic program optimization mindset
– Demonstrated success influencing senior, multinational stakeholders

If you are ready to broaden your CMC leadership scope toward enterprise-level ownership, we encourage you to apply.

How Your Day Flows

Your day typically starts by triaging the highest-impact CMC topics: timelines, open risks, and cross-site dependencies. You’ll move between focused working sessions and senior-level touchpoints—aligning internal functions with CDMOs, packaging and logistics partners, and other external stakeholders.

As issues surface, you’ll facilitate rapid root-cause discussions, confirm decision paths, and keep communications crisp for executive audiences. You’ll also carve out time to review program status and ensure teams have the clarity and support needed to maintain momentum.

Working fully remote on an Eastern schedule (Mon–Fri, 8am–5pm), you’ll balance deep technical context with pragmatic delivery, keeping late-stage activities progressing without unnecessary friction.

Total Rewards

Beacon Therapeutics (USA) Inc offers a comprehensive benefits package designed to support long-term health and financial stability, including Medical, Dental, and Vision coverage; 401(k); Life Insurance; Health Savings Account (HSA) and Flexible Spending Account (FSA) options; Employer paid STD & LTD benefits; Paid Time Off; and Employee Discounts. This role is offered with a Competitive Salary range of $240,000–$270,000.



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

MA, US

Cambridge

Posted 1 month ago

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.

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.



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