Sr. Commercial Manufacturing API Manager

Neurocrine Biosciences•San Diego, CA

About The Position

Neurocrine Biosciences is seeking a Sr. Commercial Manufacturing API Manager to oversee relationships, contracts, and activities with commercial contract manufacturing organizations (CMOs) and/or contract packaging organizations (CPOs) in its supply chain network. The role serves as the primary contact for assigned organizations and leads technical discussions and reviews of manufacturing and packaging documentation. It develops and executes operational oversight policies for cross-functional activities at contract sites, ensures contractual commitments are met, and is accountable for supplier performance, including delivery, operational metrics, budgets, and risk mitigation. The position oversees planning, scheduling, manufacturing and/or packaging, and quality control activities to ensure timely product availability and appropriate inventory levels. When needed, it also supports sourcing raw materials, utilities, and outside services for commercial manufacturing or packaging operations. The manager works with internal teams, CMOs, and CPOs to define requirements, manage priorities, ensure predictable delivery, improve processes, oversee supplier performance, support validation and agreements, and partner with Quality Assurance on compliance with cGMP and Neurocrine requirements.

Requirements

BS/BA degree in Engineering, Science, or a related field and 8+ years of experience in CMC Manufacturing, Process Development, Packaging Operations, Packaging Development, or Engineering in the pharmaceutical industry; alternatively, a Master's degree in Engineering, Science, or a related field and 6+ years of such experience.
Experience manufacturing or packaging solid oral dosage products, with emphasis on drug substance operations or packaging operations.
Direct experience manufacturing and/or packaging marketed products.
Experience in a cGMP-regulated environment, including knowledge of relevant US/EU regulatory and quality requirements, standards, and practices.
For the Master's degree pathway, previous managerial or functional management experience is also required.
Expertise with CMC and/or packaging contract manufacturers, including technology transfer, validation, and commercial-scale production.
Extensive knowledge of CMC manufacturing and/or packaging processes for small molecules and gene therapy products.
Understanding of project planning, resource management, and collaboration with CMC Development, Quality, and Regulatory functions.
Understanding of contracts, work orders, budgeting, and cost control.
Knowledge of risk management methods such as FMEA and process improvement tools such as Lean/Six Sigma and CPV.
Broad understanding of the processes, procedures, and systems used to accomplish the team's work, and familiarity with underlying concepts in other disciplines within the function.
In-depth understanding of how the discipline integrates within the function and contributes to Neurocrine's business objectives.
Ability to influence and drive decision-making through fact-based analysis and rationale.
Ability to prioritize and multitask in a fast-paced environment, with a strong sense of urgency, accuracy, and follow-through.
Analytical and creative problem-solving skills.
Excellent written, oral, interpersonal, and presentation skills.
Demonstrated ability to work collaboratively across functions.

Responsibilities

Lead and collaborate with internal cross-functional teams and CMOs to determine commercial manufacturing and/or packaging requirements, identify and mitigate risks, and ensure plans are executed.
Interact regularly with senior management regarding manufacturing and/or packaging operations.
Manage stakeholder priorities across Neurocrine commercial activities at CMOs and CPOs.
Establish and ensure adherence to schedules, work plans, and performance requirements.
Ensure on-time and predictable delivery of products and projects at assigned CMOs and/or CPOs.
Review pre- and post-production documents, including master and executed batch records, protocols, and technical reports, and manage their approval process.
Manage CMO and/or CPO operational schedules, timelines, and costs to meet cost, quality, metrics, delivery, and program objectives.
Manage operational risks at CMOs and/or CPOs.
Provide management and person-in-plant coverage at assigned CMOs and/or CPOs for critical production activities when needed.
Analyze and champion process improvements and solutions to complex issues at CMOs and CPOs.
Develop, execute, and own the supplier management process, including scorecards and appropriate controls, oversight, and monitoring.
Support preparation and negotiation of RFQs, RFPs, Statements of Work, and Supply Agreements.
Support validation activities for commercial products at assigned CMOs and/or CPOs.
Partner with Neurocrine Quality Assurance to ensure CMOs and/or CPOs comply with cGMP guidelines and Neurocrine SOP requirements.
Support optimization of spend and resource allocation at CMOs and/or CPOs.
Oversee timely planning, scheduling, manufacturing and/or packaging, and quality control of production operations; ensure product availability and inventory maintenance at minimum acceptable levels.
When required, source and supply raw materials, utilities, and outside services supporting commercial manufacturing and/or packaging operations.
Perform other duties as assigned.