TEMP Senior Specialist, External Development – API

At Neurocrine Biosciences we pride ourselves on having a strong inclusive and positive culture based on our shared purpose and values. We know what it takes to be great and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

Neurocrine Biosciencesis a leading neuroscience-focused biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological neuroendocrine and neuropsychiatric disorders. The companys diverse portfolio includes FDA-approved treatments for tardive dyskinesia chorea associated with Huntingtons disease classic congenital adrenal hyperplasia 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 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 and follow the company onLinkedInXandFacebook. (*in collaboration with AbbVie)

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.
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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

• Bachelors 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 dont line up to exactly what we have outlined in the job description.