Sr. Specialist, QC

Who We Are:

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.

What We Do:

Neurocrine Biosciences is 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, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)

About the Role:

Responsible for reviewing GMP analytical testing performed by contract sites and supporting internal GMP analytical laboratory operations.

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

• Review and approve API and drug product analytical records for clinical and commercial products

• Review and approve stability data supporting retest period assignment for clinical and commercial products. May perform analytical testing to support stability studies, as needed

• Review and approve analytical test method validation protocols and reports. May perform analytical testing to support validation activities, as needed

• Review and approve equipment/instrument qualification, calibration and maintenance records to support the internal GMP lab

• Participate in project teams, serving as the QC representative and escalate issues to senior Quality management when appropriate

• Interact with cross-functional team members, external manufacturing sites and contract testing labs to resolve analytical testing issues

• Participate in deviation and laboratory investigation teams

• Review and compile data for regulatory submissions

• Conduct and support audits of external vendors

• Assist during onsite inspections and inspection readiness activities

• Perform additional duties as assigned by management

Requirements:

• B.S. Degree in Chemistry, Biology, or related field and 4+ years of experience within the pharmaceutical or biotechnology industry OR

• Master’s and 2+ years of related experience

• Experience applying CGMP requirements in a Quality Control setting

• Working knowledge of quality systems and regulatory compliance requirements within a clinical and commercial drug manufacturing operation

• Experience in analytical development and/or testing in a Quality Control setting

• Experience with using electronic documents management systems, labora