Specialist, R&D Strategic Ops

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 company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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• Initiates and manages R&D contracts in collaboration with Legal, Sourcing and contract owners. Participates in vendor management activities, invoice reconciliation issue resolutions, and other responsibilities as assigned

• Coordinates, aligns, and monitors research and development activities for program-specific cross-functional plans and risks

• Coordinates project timelines to support R&D goals from both a technical and business operations perspective

• Supports outsourced development and clinical/commercial manufacturing activities, as it relates to business, contract, financial management, and/or operational efficiencies

• Manages the operational activities (schedule, timelines, cost) of the vendors, ensuring cost, quality, metrics, delivery and program objectives are met

• Manages operational risk at the vendors

• Assists in CDMO site evaluation/selection, preparation of the request for proposal (RfP) and contracting process

• Support leads and key stakeholders in the preparation of RFQs, RFPs, Statements of Work (SOW), and Supply Agreements; drafts documents and works with legal to ensure documents are processed in a timely manner

• Supports the program point-of-contact within R&D

• Collaborates with multiple functional lines (R&D, Regulatory, Quality Assurance, Clinical, Legal, Finance) within the company

• Manages meetings with internal personnel, as needed, to ensure cross-functional participation on the project teams

• Collaborates with internal cross-functional teams and vendors to determine development, clinical, and commercial manufacturing requirements, identify and mitigate key risks, and ensure that plans are executed as intended.

• May identify problems and recommend new process and/or improvements, and solutions to issues at the vendors

• Works closely with Quality Assurance to ensure vendors are in compliance with all cGLP/cGMP guidelines and Neurocrine SOP requirements

• Contributes to or may help prepare reports to track spend and plans resource allocation at contract vendors

• Other duties as assigned

• BS/BA degree in Chemistry, Biochemistry or related discipline and 2+ years of Pharmaceutical industry experience

• MS/MA degree in Chemistry, Biochemistry or related discipline and some similar experience as noted above

• PhD in Chemistry, Biochemistry or related discipline and some relevant experience; may include postdoc experience

• Hands-on experience executing and interpreting pharmaceutical analysis, and drug product unit operation processing is preferred

• Demonstrates solid level of understanding project / group goals and methods

• Demonstrates leadership and is proactive and independent with minimal supervision to complete activities and assignments

• Able to explain the process behind the data and implications of the results

• Strong knowledge of one or more scientific disciplines, becoming expert in one discipline

• Strong knowledge of scientific principles, methods and techniques

• Ability to work as part of a team; may train peers at various levels

• Excellent computer skills

• Strong communications, problem-solving, analytical thinking skills

• Detail oriented yet can see broader picture

• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency

• Strong project management skills

• Strong understanding of cGLPs and cGMPs relating to pharmaceuticals

• Must be self-motivated, detail-oriented, possess familiarity of scientific topics as they pertain to biopharmaceutical projects

• Ability to learn quickly and think independently

• Exhibit strong scientific and business acumen

• Demonstrated understanding or working knowledge of R&D disciplines including CMC, preclinical or research

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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, 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.

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