Head of Site Engineering, Gene Therapy Manufacturing

Job Description

Biogen is accelerating gene therapies that may one day help transform the way we treat neurological diseases. The Head of Site Engineering, Gene Therapy is responsible for all aspects of engineering support (Automation, Process, Plant, Validation) for Biogen’s new Gene Therapy facility. This role will lead multi-function teams to implement change and improve on existing engineering design, construction, and commissioning processes. This position will also be a member of Gene Therapy Site leadership team.

• Direct process, automation, plant, and validation engineers in the execution of the day-to-day support to gene therapy manufacturing operations
• Maintain the process equipment and systems in a safe and compliant validated state
• Identify and implement system improvements and capital upgrades to maintain and increase facility efficiencies and operations
• Support presentation of and defend the site’s engineering programs to regulatory agencies and coordinating responses to regulatory filing queries or requests.
• Provide supervision and direction to direct reports for execution and prioritization of activities to support the Gene Therapy project and manufacturing schedule.
• Maintain the equipment and engineering systems in a safe and compliant validated state. Aligning procedures and best practices across sites. Presenting department programs to regulatory agencies. Review and approve major deviations or other compliance documents.
• Support Technology Transfers and the related equipment design, installation, commissioning, and validation activities to support the manufacturing schedule
• Manage the operational expense for the gene therapy engineering team. Identify and implement system improvements and capital upgrades.
• Develop strategic vision and long-term objectives for department, and support development of strategies for process engineering, automation, plant engineering, and validation functions
• Manage annual operational expense budget, monitor the performance of the department against operational goals, and manage a group of 5-10 staff
• Provide career development and performance coaching for direct reports.

You are a strategic leader that influences business outcomes, sparks innovation and are agile in your approach. You are dedicated to contributing to the generation of pioneering gene therapies.

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Qualifications

• University degree or the equivalent combination of education and experience required; advanced/graduate degree preferred for some disciplines

• Typically requires 12-15 years'experience in pharmaceutical or biotech manufacturing environment
• 7+ years’ of people management experience
• Practical knowledge and application of GMP and FDA, EMA regulations
• Capable of working in a highly dynamic and fast paced environment. Incumbent will need to leverage agility and innovation skills to flex through site construction, start-up, and ramp-up from clinical to commercial operations.
• Broad understanding of the detailed aspects of the job
• Competency in MS Word, MS Excel, MS Power Point and MS Project
• Excellent oral and written communication skills

• Experience with AAV Gene Therapy Technologies and BSL2 and viral facility design and operations

Additional Information

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.