Sr. Commercial Manufacturing API Manager

Neurocrine Biosciences•San Diego, CA

3d•$143,600 - $196,000

About The Position

Oversees relationships, contracts, and activities for commercial contract manufacturing organizations (CMOs) and/or contract packaging organizations (CPOs) in Neurocrine’s supply chain network, serving as the single point of contact for assigned organizations. Leads technical discussions and reviews manufacturing and/or packaging documentation, and develops and executes policies for operational oversight of cross-functional activities while ensuring contractual commitments are met. Accountable for assigned organizations’ overall performance, including delivery, operational metrics, budget, and risk mitigation. Oversees timely planning, scheduling, manufacturing and/or packaging, and quality control of production operations. Ensures scheduled product availability and inventory is maintained at minimum acceptable levels. When needed, sources and supplies raw materials, utilities, and outside services in support of commercial manufacturing and/or packaging operations. The role works with internal teams, senior management, CMOs, CPOs, and Quality Assurance to deliver commercial products and projects in compliance with applicable requirements.

Requirements

Bachelor’s degree in Engineering, Science, or a related field and 8 or more years of CMC manufacturing, process development, packaging operations, packaging development, or engineering experience in the pharmaceutical industry; alternatively, a master’s degree in one of these fields and 6 or more years of such experience.
For the master’s degree pathway, previous managerial or functional management experience is also required.
Experience with manufacture or packaging of solid oral dosage products, with an emphasis on drug substance operations or packaging operations.
Direct experience with the manufacture and/or packaging of marketed products.
Experience working in a cGMP-regulated environment, including knowledge of relevant US and EU regulatory and quality requirements, standards, and practices.
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, 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.
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.
Regularly interact with senior management regarding manufacturing and/or packaging operations.
Manage stakeholder priorities across Neurocrine commercial activities at CMOs and CPOs.
Establish schedules, work plans, and performance requirements, and ensure adherence.
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 activities, schedules, timelines, and costs to meet cost, quality, metric, delivery, and program objectives.
Manage operational risk at assigned CMOs and/or CPOs.
Provide management and person-in-Plant coverage at assigned CMOs and/or CPOs for critical production activities as needed.
Analyze and champion process improvements and solutions to complex issues at CMOs and CPOs.
Develop, execute, and own the supplier management process, including relevant 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.
Perform other duties as assigned.