TEMP - Senior Specialist, External Development – API

Neurocrine Biosciences•San Diego, CA

1d•$53 - $77

About The Position

The Senior Specialist, External Development – API supports the management, coordination, and performance oversight of external suppliers within the Technical Operations organization. This role contributes to the execution of supplier strategies across a global network of CMOs, CDMOs, raw material suppliers, and service providers supporting development, manufacturing, testing, and supply activities. The Senior Specialist partners cross-functionally with API Development, Pharmaceutical Development, and Quality, to ensure external partners are effectively engaged, aligned with program needs, and operating in accordance with technical, quality, and business requirements. This individual plays a key role in day-to-day supplier management, issue resolution, and execution of outsourcing strategies.

Requirements

Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; advanced degree (MS/MBA) preferred
Typically 5–8 years of relevant experience in pharmaceutical/biotech development, manufacturing, or external/vendor management
Demonstrated experience managing external suppliers (CMOs/CDMOs) or complex cross-functional projects
Strong understanding of API development, manufacturing, and GMP/GxP requirements
Experience with supplier performance management, project management, or outsourcing models preferred

Responsibilities

External Supplier Management & Governance Support execution of supplier management strategies across Technical Operations
Participate in supplier governance activities, including routine business/development reviews, performance tracking, and communication frameworks
Ensure alignment of external suppliers with program timelines, technical requirements, and supply needs
Serve as a primary or supporting point of contact for assigned external suppliers
Maintain effective working relationships with external partners to support program execution
Manufacturing Strategy & Execution Contribute to implementation of external manufacturing strategies aligned with development needs
Support coordination of activities with external manufacturing organizations to ensure timely and compliant delivery
Participate in supply planning and capacity discussions with internal stakeholders and external partners
Supplier Performance & Relationship Management Manage day-to-day activities for assigned suppliers, including tracking deliverables, timelines, and issue resolution
Coordinate cross-functional teams and external partners to address operational challenges and maintain project execution
Monitor supplier performance using KPIs (quality, delivery, cost) and escalate issues as appropriate
Support preparation and execution of periodic business and performance review meetings
Assist in maintaining productive working relationships with supplier counterparts
Negotiations & Contract Support Support contract-related activities including scope definition, change orders, and amendments in collaboration with senior team members
Assist in RFP preparation, bid evaluation, and supplier selection processes
Contribute to discussions on pricing, timelines, and service expectations
Outsourcing Execution & Cross-Functional Collaboration Partner with Technical and Quality teams to support supplier onboarding and lifecycle management
Participate in supplier evaluations and site assessment activities as needed
Facilitate communication and alignment between internal stakeholders and external partners
Quality, Compliance & Risk Management Ensure assigned suppliers operate in compliance with applicable GMP/GxP and regulatory requirements
Partner with Quality to support audits, quality events, and issue resolution
Identify and communicate potential risks related to supply, compliance, or performance, and support mitigation activities
Financial & Operational Support Support tracking and monitoring of external supplier spend and budgets
Assist in evaluating cost drivers, scope changes, and financial impacts of outsourcing activities
Contribute to cost optimization efforts while maintaining quality and supply continuity
Process Improvement & Scalability Contribute to the development and improvement of supplier management processes, tools, and templates
Support continuous improvement initiatives related to outsourcing and supplier performance
Help implement standardized practices across the external network
Market Awareness Maintain awareness of the external manufacturing landscape, including CDMOs and supplier capabilities
Monitor industry trends, capacity considerations, and emerging technologies relevant to API development and manufacturing
Support internal discussions with relevant market insights
Other Responsibilities Perform additional duties as assigned in support of Technical Operations and organizational objectives