The Business Operations Lead is an integral member of the Biologics External Supply Leadership team. External Supply manages supplier relationships within the Biologics Operating Unit organization to achieve Shire’s Corporate objectives
The Business Operations Lead may be expected to:
• Develop and implement ways of working/business processes and guidelines to define standard ways of working across the SRM team
• Manage CMO lifecycle including selection, technology transfer, manufacturing, and decommissioning.
• Lead and/or contribute to tactical and strategic sourcing activities
• Biologics point person for Contract Manufacturing Center of Excellence (CoE) responsible for developing common best practices to manage external partnerships and the Community of Practice (CoP) to drive continuous improvement of the model in partnership with the CMOs.
• Lead small team of direct or indirect reports
- Work with Shire stakeholders to develop and monitor short-term and long-term plans, including timelines, budget forecasts, for achieving department strategies.
- Develop and deploy a Governance Process for Outsourced Relationships that is both standardized in philosophy and fit for purpose in magnitude relative to the size and importance of the relationship
- Develop and implement standardized process for proposals
- Create and manage tracking system for in process and completed proposals, SOWs, and contracts.
- Develop standardized system for SRM’s to monitor and drive adherence to Shire’s and CMO contractual commitments, obligations, and processes, including milestone dates, financial terms, and production schedules both internally and externally.
- Establish, track, monitor, and report performance metrics related to operations, quality, cost, and customer service. Develop and distribute periodic reports on CMO performance, issues, risks, and schedules of key activities, events, or milestones.
- Develop, implement and maintain processes and systems for new product introductions/new launches within the supply base
- Partners with Head of the Contract Manufacturing CoE to create alignment across Tech Ops around a proven set of outsourcing best practices through the creation and maintenance of a CoE and a community of practice for Tech Ops.
- Ensure a common understanding of the current Best Practices and ensure that they are documented and deployed through training and process implementation
- Provide direct support as required to ensure supply and the resolution of challenges within the within the outsourced environment for Tech Ops
- Support implementation of Continuous Improvement initiatives (including Lean Sigma) at suppliers/CMO’s
- At times may independently execute an RFP or negotiate moderate scope manufacturing supply agreements meeting Shire supply, quality, financial and risk mitigation requirements
Education and Experience Requirements:
- Bachelor/ Master’s Degree in Engineering, Biotechnology, Business or scientific field
- Minimum of 10 years relevant clinical/commercial Pharmaceutical experience
- Strong project management, problem solving, decision making, collaboration, influence, and facilitation skills.
- Experience leading cross-functional teams to overcome hurdles and deliver project results on time and as expected.
- Interpersonal skills necessary to develop effective working relationships with internal stakeholders and represent the External manufacturing organization on cross-functional and cross-cultural project teams.
- A working knowledge of biotech/pharma manufacturing operations, product and process development, and supply chain operations
- Ability to effectively communicate and persuade others at every level to accomplish challenging tasks
- Able to negotiate and manage contracts
- Experienced in risk management processes
- Excellent clinical/commercial API, DP & FDP sourcing and manufacturing knowledge a plus
Req ID: R0019184