Head of Global Manufacturing Sciences

Job Description

*Position can be based in Cambridge, MA, RTP, NC, Baar or Solothurn Switzerland.*

Reporting to the SVP of Global Manufacturing and Technical Operations (GMTO), this position leads the Global Manufacturing Sciences (GMS) department in Biogen’s GMTO function.  In this role, you will manage overall manufacturing responsibilities across the portfolio, technical transfer of processes and methods (both Biogen internal assets and strategic partner programs run in Biogen) into internal factories and external CDMO plants, including (in differing proportions of shared accountability with Development, depending on modality) early clinical programs, late-stage/PPQ, and commercial programs going to new sites.  Deploys GMS technical TT leads, technical product leads, process SMEs, Process Sciences labs/scientists, Materials Sciences lab/scientists, and data analytics scientists to ensure new campaign success; materials and consumables suitability for use; supplier technical readiness; tools for campaign, batch, and materials visibility; process troubleshooting and correction; and development and implementation of lifecycle process improvements for commercial assets.  You will also ensure that new processes, materials, control technologies, and monitoring approaches and tools are manufacturing-ready in a phase-appropriate/stage-gated manner.

MAIN RESPONSIBILITIES

With broad accountability in driving the shared goals of GMTO and PO&T, this leader sits on the Senior Leadership Team (SLT) for GMTO and provides insight and recommendations to guide and set the strategy for the overall GMTO organization and interacts with/presents to the PO&T SLT as needed.  In this role, you must also maintain a degree of visibility to tactical considerations and issues that relate to or impact clinical and commercial processes, as well as the transfer of processes into internal factories and external plants.  You will partner collaboratively with peers and leaders in the other PO&T line functions to ensure that GMTO is ready to both receive and execute new processes/products, and to ensure that new technologies for process and plant are robust, implementable, and sustainable in a manufacturing environment.  You will serve on joint steering committees for major strategic partners.

As a leader of GMS, the role is highly impactful to GMTO operations and to the success of PO&T’s assets: this team’s work ensures successful timelines for starting and completing clinical and PPQ campaigns in high run-rate plants and CDMOs; technical support during clinical and commercial campaigns; timely investigation and correction of manufacturing process issues; and contribution to and review of key sections of regulatory filings for new assets.  Ensures that late-stage processes are ready for process validation, and owns and drives the process validation master plan, protocols, and reports.  The Materials Science team ensures vendor technical readiness for raw material and consumables supply to Biogen and provide raw materials analytical characterization and monitoring to look for “unknowns” before materials are committed to GMP batches.  The site teams provide expert process support as needed for Operations, both internally and externally. Also, they provide technical management of strategic partner relationships, including tech transfer and batch/campaign/issue visibility for partners.

• Directs direct reports (GMS Leadership Team) to ensure success in meeting PO&T’s strategic goals and Asset Team timelines and milestones.  Sets strategy and goals of GMS to align with GMTO and PO&T and responds agilely to new asset acquisition and partner opportunities as they arise.  Ensures that GMS site and global line functions are working in a matrixed framework to drive the needs of internal asset timelines, strategic partner program timelines, and GMTO.
• Partners with leadership in Global Engineering, Manufacturing, ADPM, Quality, and Regulatory Affairs to ensure that cross-functional teams are working smoothly to deliver and maintain processes and controls that are timely, phase-appropriately ready for manufacturing, and compliant, to meet clinical and commercial Supply Chain needs.
• Understands and responds to business priorities and translates into tactical objectives and work direction for the site MS teams.  Includes the direct and matrixed GMS team listed above.  Ensures that production schedules and Asset Program deliverables are not compromised due to tech transfer/process transfer issues, partnering with the other GMS line functions as required.
• Manages budget (~$22MM OPEX, ~$2.5MM CAPEX yearly), staffing, and performance management duties for GMS.  Mentors direct and indirect reports on development planning and possibilities for their careers, both within GMS and across Biogen.
• Ensures compliance of investigative