Head of Manufacturing, OSM & OSD

Job Description

About This Role:

This key member of the RTP Pharma Site Leadership Team (SLT) leads and directs all cross-functional I departmental activities associated with the Oligonucleotide Synthesis Manufacturing (OSM) and Oral Solid Dose (OSD) operations facilities. This role provides operations leadership and strategy in all areas of production to ensure an uninterrupted supply of quality products to our customers within the Biogen global drug supply network. 

What You'll Do:

• Establish and refine an operational vision and strategy (near and long terms) that ensures the highest standards of employee safety and environmental protection, the highest standards of compliance and overall operational excellence.
• Direct and lead Area Managers and Manufacturing Support functions - observing/instructing, coaching, leading and developing the staff. Foster a high level of communication and coordination between the production operations and the support departments to address issues and meet production schedules.
• Ensure operational support for clinical, development, engineering, validation, and commercial batches for new products. Ensures Managers and Direct Support Functions are adequately trained and have necessary resources and capabilities to run the manufacturing areas.  Approve batch documentation and sitewide technical reports, protocols, change control and deviations.
• Create, approve, and drive alignment for site-wide strategies, aligning with Network strategies, corporate priorities, and business needs.  Develop the operational goals and ensure proper prioritization and resourcing to achieve them.
• Ensure manufacturing activities are performed per cGMP and appropriate Safety procedures. Troubleshoots operational and equipment-related problems, working with cross-functional stakeholders (Manufacturing Sciences, Engineering, Quality, Planning, etc.)
• Constantly monitor performance - ensuring the operations are achieving cost performance targets and operational excellence goals; managing plans associated with new product introductions, demand increases, facility utilization and capital spending.
• Partner with Factory-decided Learning Lead to develop annual learning strategies aligned to business strategy and goals. Engage Learning Lead to build programs that focus on factory need and performance support for direct production activities, and continually look for ways to share and implement learning and training best practices across factories and sites. Identify technical/non-technical development gaps and implement applicable plans/objectives.

Who You Are:

An experienced Biotech/Pharmaceutical Manufacturing Operations leader that is driven by the challenge of leading teams engaged in complex and dynamic operations.

Qualifications

Required:

• Bachelor’s Degree from a four-year college or university with an emphasis on Biotechnology, Life Sciences, and/or Engineering (Master's Degree preferred)
• Minimum of 12 years of experience in biopharmaceutical operations
• Minimum of 5 years of senior operations management experience
• Excellent planning and organizational skills
• Strong customer focus and ability to lead through ambiguity
• Excellent understanding of the finance/budgeting process associated with manufacturing operations

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.

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 expre