Job Information
Biogen Head of Automation & Manufacturing Execution Systems (MES), RTP Bio in Research Triangle Park, North Carolina
About This Role:
The Head of Automation & MES is a key member of the RTP Bio site leadership team and manages a site-based group accountable to the safe development, implementation and operational compliance of the Biogen RTP Bio execution philosophy and associated plant execution/operations systems for all batch activities (both process and analytical testing), as well as supporting infrastructures. Plant execution/operations systems include DCS, MES, PLC, BMS and data systems such as historian and analytics solutions.
The RTP Bio site is home to our Large-Scale Manufacturing (LSM), Small Scale Manufacturing (SSM), and Flexible Volume Manufacturing (FVM) operations. Our campus is comprised of 7 buildings and a central utilities area which includes an Administration building, our LSM, SSM, & FVM plants, Manufacturing Sciences (MS) and Quality Control (QC) labs, Development Pilot Plant, and Warehouse operations.
What You'll Do:
Setting and driving strategic priorities for the holistic systems technology landscape for the site, including but not limited to oversight of new plants/ facilities, changes to plant execution/operations systems, automation engineering systems, developing and maintaining validation lifecycle strategy etc. Implementing, validating, maintaining and governing S95/S88 Standards, Libraries, Interfaces & Systems.
Being accountable to the delivery of all aspects of plant execution/operations systems to support site commissioning, validation, and on-going safety, compliance and quality manufacturing. This includes developing strategic partnerships with Biogen global organizations, across the industry and involvement/participation in industry forums to exchange knowledge and best practices.
Ongoing support and maintenance of all aspects of the plant execution/operations systems. Single Point of Contact for all plant execution/operations systems to key functions such as Manufacturing, Quality, Engineering, Manufacturing Sciences, Facilities and Maintenance.
Developing and managing a high performing team to deliver on above responsibilities. Create and sustain a culture of innovation, quality, compliance, accountability, employee engagement, collaboration, diversity and inclusion. Lead the site organizations through uncertain times or through large-scale, transformational change.
Owning and overseeing all capital & operational expenditures of plant execution/operations systems.
Who You Are:
You are an experienced Automation Engineering leader with both experience in and a passion for managing multi-functional Automation and MES teams in a GMP environment focused on drug substance manufacturing.
Required:
Bachelor’s Degree (BA/BS) from a four-year college or university in Engineering, Computer Science or other related field (M.S. or PhD strongly preferred)
Minimum of 15 years of related experience in the Biotechnology/Pharmaceutical industry in an operational role
Minimum of 5 years of managing technical teams (Automation Engineering and Manufacturing IT) as well as collaborating with multidisciplinary cross-functional teams.
Demonstrated track record of success and leadership positions of increasing responsibility. A mindset of accountability, inclusiveness, agility, innovation and collaboration
Technical experience and competence with implementation of DCS and MES systems is required; experience with data systems (such as historians). PLC and BMS systems experience are desired but not required
Familiarity with industry standards for execution/operations system such as S88, S95, GAMP, computer systems validation and others
Formal and/or on the job experience in business practices including budget management, project management, and strategic planning
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.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.