Job Description

ABOUT THIS ROLE

Biogen is accelerating its capacity within gene therapy operations with the focused goal that one day we will help transform the way we treat neurological diseases.  The Manufacturing Manager for Biogen’s Gene therapy Manufacturing (GTM) Facility at Research Triangle Park (RTP) supervises a team of Manufacturing Associates, schedules shift tasks and ensures GMP compliance and safety.  During the start-up of the new facility other duties will include drafting and review of manufacturing documents, supporting the cross functional teams for testing, and qualification of equipment and facilities.  The role will include manufacturing operational & technical leadership throughout commissioning, training, qualification and start-up of GMP operations for the site.

WHAT YOU’LL DO

• Build and supervise a team of Manufacturing Associates ensuring appropriate training and focus on the personal and team development
• Oversee and direct manufacturing activities per cGMPs to meet project milestones and deliverables within budget
• Troubleshoot operational and equipment issues as well as managing change throughout the project and operations
• Reviews GMP documents for accuracy, completeness and compliance
• Provide overall direction, coordination and evaluation of multiple direct reports and indirect reports for a Manufacturing Organization that operates over multiple shifts.
• Conduct briefings and participates in technical meetings for senior management and external representatives concerning specific operations
• Develop and implement metrics/KPIs to monitor operational health, inform strategic decisions.

Qualifications

WHO YOU ARE

You are able to work shifts (day or night) managing a team of Manufacturing Associates in a GMP Biological Manufacturing Facility and are an established expert in one or more biomanufacturing departments (Cell Culture/Upstream or Purification/Downstream).  You are passionate leader adept at leading a team in times of routine, as well as non-routine production activities. You are a strong team-oriented communicator, dedicated to contributing to the generation of pioneering gene therapies for our patients.

REQUIRED SKILLS

• Bachelors 4+ years of relevant experience, Master's Degree 3+ years of relevant experience or PHD with 1+ years of relevant experience, or the equivalent combination of education and experience 
• Demonstrated knowledge of biomanufacturing process and equipment
• Expert level of understanding cGMP compliance and experience with multiple regulatory inspection agencies such as EMEA and FDA
• Availability to address urgent issues outside of typical work hours (i.e. weekends, non-scheduled work-days)
• Experience coaching, developing and managing a staff of shift employees.

PREFERRED SKILLS

• BS degree in scientific field
• 2+ Years leadership experience
• Prior experience in Gene Therapy Manufacturing Operations is preferred.  
• Knowledge of aseptic processing/cell culture/cell and gene therapy manufacturing is desirable.
• Ability to influence final decisions on administrative or operational issues affecting major segments or activities of the function.
• Lean Manufacturing, Six Sigma, Human Performance (HOP), or Operational Excellence experience

Additional Information

WHY BIOGEN?

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.