Director/Senior Director, Contract Manufacturing Operations
SUMMARY: The Director/Senior Director, Contract Manufacturing Operations manages the relationships, contracts, and activities of assigned commercial contract manufacturing organizations (CMOs) within the Neurocrine supply chain network. The role serves as strategic lead and primary point of accountability, and provides operational oversight of all cross-functional activities at the commercial contract manufacturing sites, while ensuring that contractual commitments are honored. The role is accountable for the overall performance of assigned CMOs, including budget, deliverables, operational metrics, and risk mitigation.
ESSENTIAL DUTIES AND RESPONSIBILITIES (include, but are not limited to):
- Collaborates with internal cross-functional teams and CMOs to determine commercial manufacturing requirements, identify and mitigate key risks, and ensure that plans are executed as intended.
- Drives commercial contract manufacturer capability and capacity to enable on-time and predictable delivery of products and projects.
- Identifies and champions process improvement, and solutions to complex issues at the CMOs.
- Provides visibility to key stakeholders on all CMO matters, tactical & strategic, and manages stakeholder priorities across all Neurocrine activities at the CMOs.
- Manages the operational activities (schedule, timelines, cost) of the CMOs, ensuring cost, quality, metrics, delivery and program objectives are met. Manages operational risk at the CMOs.
- Develops, executes and owns the commercial supplier selection and management processes including relevant scorecards, to ensure appropriate controls, oversight and monitoring are in place
- Partners with key stakeholders in the preparation and negotiation of RFQs, RFPs, Statements of Work (SOW), and Supply Agreements.
- Partners with Neurocrine Quality Assurance to ensure CMOs are in compliance with all cGMP guidelines and Neurocrine SOP requirements
- Creates synergies in spend and resource allocation at the CMOs
- Direct and proven CMO and Manufacturing Operations experience.
- Demonstrated success in project planning, resource management, and collaboration with Development, Quality and CMC.
- Demonstrated ability to negotiate and manage contracts, and establish and control budgets
- Experience working in a cGMP-regulated environment, including knowledge of relevant US/EU regulatory and quality requirements, standards, and practices.
- Demonstrated ability to lead a team, and get things done through influence in a matrix environment
- Strong business knowledge of biotech/pharma manufacturing operations, product and process development, finance, and supply chain operations
- Strong analytical and creative problem solving skills.
- Strong compliance orientation and attention to detail within a cGMP environment
- Effective communicator at all levels; excellent written, oral and interpersonal communications and presentation skills.
- Experience with manufacturing of solid oral dosage products, including API, drug product and packaging
- Direct experience with new product launches.
- Knowledge of Lean / Six Sigma and risk management tools (e.g., FMEA).
EDUCATION and/or EXPERIENCE:
- Bachelor’s degree in Engineering, Science, or Business; advanced degree preferred
- 15 Years of Manufacturing, Engineering, Supplier Management or Procurement experience
- 10+ Years in the Pharmaceutical industry
OTHER WORKING CONDITIONS:
- Requires ability to travel minimum of 25% in US, Europe and possibly other countries.