Sr. Commercial Manufacturing API Manager

Neurocrine Continental; San Diego (CA); On-site; USD 170,000 - 190,000; Full time

Job summary

Neurocrine Biosciences is seeking a senior professional to oversee commercial CMO/CPO relationships for packaging and manufacturing. You will lead technical reviews, ensure site performance, and drive cross-functional collaboration to meet supply commitments.

The role requires a BS/BA in Engineering or Science and 8+ years in CMC manufacturing, process development, or packaging within the pharmaceutical industry. Hybrid guidance may apply to packaging operations.

Qualifications

• 8+ years in CMC manufacturing, process development or packaging in pharma.
• Experience with solid oral dosage manufacturing/packaging.
• Understanding of cGMP guidelines and regulatory expectations.

Responsibilities

• Lead and oversee CMOs/CPOs relationships and performance.
• Developed policies for operational oversight of contract sites.
• Ensure on-time delivery, budget adherence, and risk mitigation.
• Manage schedules, cost, quality, and supplier scorecards.
• Support RFQs, RFPs, and Statements of Work with QA alignment.
• Coordinate validation activities for commercial products.

Skills

CMC Manufacturing

Process Development

Packaging Operations

Engineering Experience

Solid oral dosage

Education

BS/BA degree in Engineering, Science or related field

Job description

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com , and follow the company on LinkedIn , X , Facebook and YouTube . ( *in collaboration with AbbVie )

About the Role:

Oversees the relationships, contracts, and activities of commercial contract manufacturing organizations (CMOs) and/ or Contract Packaging organization (CPOs) within the Neurocrine supply chain network. Serves as the single point of contact for all aspects of the relationship with commercial CMOs and/ or CPOs. Leads technical discussions and technical review of manufacturing and/or packaging documentation. Develops and executes policies on operational oversight of all cross-functional activities at the contract manufacturing and or packaging sites, while ensuring that contractual commitments are honored. Accountable for the overall performance of assigned CMOs and/or CPOs, including delivery, operational metrics, budget, and risk mitigation. Oversees activities related to the timely planning, scheduling, manufacturing and/or packaging, and quality control of production operations. Ensures the availability of relevant products in the supply chain, as scheduled, and the maintenance of inventory at minimum acceptable levels. When required, responsible for sourcing and supplying raw materials, utilities and outside services in support of commercial manufacturing and or packing development operations. _

Your Contributions (include, but are not limited to):

• Leads and collaborates with internal cross-functional teams and CMOs to determine commercial manufacturing and/or packaging requirements, identify and mitigate key risks, and ensure that plans are executed as intended
• Regularly interacts with senior management on matters concerning manufacturing and/or packaging operations
• Manages stakeholder priorities across all Neurocrine commercial activities at CMOs and CPOs
• Establishes and ensures adherence to schedules, work plans, and performance requirements
• Ensures on-time and predictable delivery of products and projects at assigned CMOs and or CPOs
• Reviews pre- and post-production documents (e.g., master and executed batch records, protocols, technical reports), and manages the approval process for the same
• Manages the operational activities (schedule, timelines, cost) of the CMOs and or CPOs, ensuring cost, quality, metrics, delivery and program objectives are met
• Manages operational risk at the CMOs and or CPOs
• Provides management of and person-in-Plant coverage at assigned CMOs and or CPOs, for critical production activities as and when needed
• Analyzes, identifies and champions process improvement, and solutions to complex issues at the CMOs and CPOs
• Develops, executes and owns the supplier management process including relevant scorecards, to ensure appropriate controls, oversight and monitoring are in place
• Supports the preparation and negotiation of RFQs, RFPs, Statements of Work (SOW), and Supply Agreements
• Supports validation activities for commercial products at assigned CMOs and or CPOs
• Partners with Neurocrine Quality Assurance to ensure CMOs and or CPOs are in compliance with all cGMP guidelines and Neurocrine SOP requirements
• Supports the optimization of spend and resource allocation at the CMOs and or CPOs
• Other duties as assigned

Requirements:

BS/BA degree in Engineering, Science or related field AND 8+ years of CMC Manufacturing, Process Development, Packaging Operations, Packaging Development or Engineering experience in the Pharmaceutical industry. Experience with manufacture or packaging of solid oral dosage products, with an emphasis on dru