TEMP - Senior Specialist, External Development API

Senior Specialist, External Development API

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.

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

• 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

Requirements:

• Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; advanced degree (MS/MBA) preferred

• Typically 58 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

The pay you should reasonably expect to receive is $53.27 - $77.21 per hour. Decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.

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Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.