Manager / Senior Manager, Packaging Operations
SUMMARY: The Manager / Senior Manager, Packaging Operations will ensure that marketed products are packaged into finished goods in a reliable, compliant, cost-effective and timely fashion to meet commercial demand. This role manages the relationships, contracts, and activities of assigned commercial contract packagers within the Neurocrine supply chain network. The role serves as the operations lead and primary point of accountability for commercial packaging, and provides project management oversight of cross-functional activities at all commercial contract packaging and related supplier sites, while ensuring that contractual commitments are honored. The operational scope includes primary, secondary and tertiary packaging of bulk drug product into finished goods, including artwork, serialization and anti-counterfeiting measures. The role is accountable for the overall performance of assigned commercial contract packagers, 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 contract packagers to determine packaging requirements, identify and mitigate key risks, meet regulatory requirements, and ensure that plans are executed as intended.
- Drives contract packager 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 contract packagers.
- Provides visibility to key stakeholders on all packaging matters, tactical & strategic, and manages stakeholder priorities across all Neurocrine activities at the contract packagers.
- Manages the operational activities (schedule, timelines, cost) of the contract packagers, ensuring cost, quality, metrics, delivery and program objectives are met. Manages operational risk at the contract packagers.
- Develops, executes and owns the 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 for existing and potential contract packagers.
- Partners with Logistics and Trade Compliance to coordinate inbound and outbound shipments at contract packagers.
- Partners with Neurocrine Quality Assurance to ensure contract packagers are in compliance with all cGMP guidelines and Neurocrine SOP requirements, e.g., change control procedures.
- Direct and proven packaging experience in the pharmaceutical industry, including project management, packaging validation and commercial scale production.
- Demonstrated success in project planning, resource management, and collaboration with Development, Quality and CMC.
- Demonstrated ability to 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 pertaining to primary and secondary packaging.
- Demonstrated ability to work collaboratively, and get things done through influence in a matrix environment
- Business knowledge of biotech/pharma packaging operations, product supply, 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 packaging of solid oral dosage products, and knowledge of different container closures, packaging components, package design, and artwork management.
- Experience with new product launches.
- Knowledge of Lean / Six Sigma and project management tools.
EDUCATION and/or EXPERIENCE:
- Bachelor’s degree in Engineering, Science, Pharmacy, Supply Chain Management, Operations Management, or equivalent
- Minimum of 5 years direct experience with packaging operations and project management in the biotech / pharmaceutical industry
OTHER WORKING CONDITIONS:
- Requires ability to travel minimum of 25% primarily in the US but possibly other countries as well.
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.