Sr. Scientist, Bioanalytical (Gene Therapy)

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.

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, visitneurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

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• Lead the development, qualification, and analysis of biodistribution and viral shedding studies in gene therapy programs

• Work collaboratively with internal project teams as well as with CROs to support preclinical drug development activities

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

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

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

• Act as a subject matter expert in gene therapy bioanalysis, providing scientific guidance to internal and external teams

• 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

• 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

• PhD or equivalent and some industry experience; may include postdoc experience OR

• Experience with AAV therapeutics development is strongly preferred

• Knowledge of regulatory requirements for bioanalytical assays

• Familiarity with viral vector quantification and emerging technologies for gene therapy such as digital droplet PCR and ELISPOT

• Developing the ability to recognize anomalous and inconsistent results and interprets experimental outcomes

• Developing strong knowledge of scientific principles, methods and techniques

• Ability to work with a variety of laboratory instrumentation and/or PK analysis and or modeling and simulation software

• Excellent computer skills

• Developing problem-solving, analytical thinking skills

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

• Degree in biology, chemistry, or related science, preferably with experience in a bioanalytical laboratory

• Background in bioanalytical job-relevant core competency (immunoassays such as ELISA, handling of a variety of biological matrices such as serum and plasma, automation, method

  development/validation GLP studies, biomarker analysis)

• Hands-on experience with role-appropriate technology and methodology such as: automation, radioisotope use, PK analysis and modeling and simulation software

• Previous experience in cross-functional teams and in a scientific or clinical setting supporting drug development

• Developing strong written and verbal communication skills

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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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