Sr. Scientist, Bioanalytical (PK/ADA)

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, but few options.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. 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, 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 (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

The Bioanalytical Senior Scientist, as part of the preclinical team, will develop and perform immunoassays to quantify large molecule therapeutics in biological fluids and tissues with a focus on pharmacokinetics (PK) and immunogenicity (ADA) assessments. The qualified individual will be responsible for the implementation of various types of assay platforms (e.g., ELISA, electrochemiluminescence) to answer key questions related to pharmacokinetics, pharmacodynamics, and immunogenicity in a regulated setting. This role is ideal for a candidate with a strong foundation in regulated bioanalytical analysis of biologics, with experience in PK and ADA methodologies, and data interpretation to support the preclinical development of therapeutics.

_

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

• Develop custom reagents and assays on various platforms (e.g., ELISA, electrochemiluminescence, Gyros) for pharmacokinetic and/or immunogenicity assessments

• Perform sample analysis to support bioanalysis efforts for non-regulated and regulated preclinical studies, including pharmacokinetics, pharmacodynamics, immunogenicity, and biological activity

• Lead the development and qualification of ADA assays (e.g. bridging electrochemiluminescence) to assess immunogenicity in biologic programs

• Work collaboratively with internal stakeholders to support CRO selection and oversee the transfer of internal assays to support regulated preclinical studies

• Lead troubleshooting efforts for both bioanalytical internal methods as well as methods at CROs to ensure data quality

• Effectively communicate results to internal/external teams in presentations and internally authored reports

• Prepare documents to support technical transfer of methods to CROs

• Manage and maintain a safe, organized, and operational laboratory space including maintenance of equipment and procurement of supplies

• May QC study reports and regulatory submissions

• Performs other duties as assigned

Requirements:

• BS/BA degree in Biology or closely related field and 5+ years of industry experience in an biotech, pharma, and/or CRO setting; Experience working in and accomplishing tasks a timeline driven setting; Experience in large molecules or biomarkers bioanalysis is preferred OR ​

• MS/MA degree in Biology or closely related field and 3+ years of similar experience noted above OR