Senior Scientist, Gene Therapy Potency – CMC Analytical Development

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:

The Senior Scientist will serve as the analytical potency SME within CMC Analytical Development, supporting biologics programs including AAV-based gene therapies, monoclonal antibodies, and antibody conjugates. This role leads the development, qualification/validation, transfer, and lifecycle management of potency assays used to monitor critical quality attributes (CQAs) of drug substance and drug product. The position defines and executes potency strategy, designs robust cell-based functional assays, and ensures regulatory-compliant data generation across all development stages in alignment with cGMP and global regulatory requirements.

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

• Act as potency SME on cross-functional CMC teams; own analytical deliverables, timelines, and risk mitigation

• Establish potency strategy aligned with mechanism of action and regulatory expectations, linking CQAs to clinical relevance

• Develop, optimize, qualify, validate, and manage lifecycle of potency assays, particularly for viral vector–based gene therapies

• Design and execute cell-based functional assays assessing transgene expression, biological activity, infectivity/transduction, and MOA-relevant endpoints

• Develop molecular and biochemical assays (qPCR/ddPCR, RT-qPCR, ELISA, reporter assays, flow cytometry, Western blot) as appropriate

• Perform statistical analysis and data interpretation; author validation protocols, technical reports, and CMC regulatory documentation

• Lead analytical method transfer to QC and CDMOs, including training and method comparability assessments

• Support IND/IMPD and BLA/MAA submissions and respond to health authority inquiries

• Ensure compliance with cGMP, ICH guidelines, and internal quality systems

• Mentor junior scientists and promote scientific rigor and collaboration

Requirements:

• PhD in Molecular Biology, Cell Biology, Virology, Biochemistry, or related field with some industry experience; OR MS with 3+ years; OR BS with 5+ years

• Demonstrated expertise in potency assay development for gene therapy products, especially AAV or lentiviral vectors

• Strong understanding of gene therapy MOA and translation into biologically relevant potency assays

• Hands-on experience with:

  • Cell-based potency assays (reporter, transduction/infectivity, functional protein expression)

  • Molecular assays (qPCR, ddPCR, RT-qPCR)

  • Flow cytometry–based assays

  • Immunoassays (ELISA, MSD)

• Experience with assay qualification/validation (ICH Q2), lifecycle management, and cGMP compliance

• Experience with analytical method transfer and CDMO collaboration

• Familiarity with FDA, EMA, and ICH regulatory expectations for gene therapy potency strategy

• Strong statistical analysis, critical thinking, and communication skills

• Effective contributor within cross-functional CMC teams

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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 don’t line up to exactly what we have outlined in the job description.

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The annual base salary we reasonably expect to pay is $110,800.00-$151,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.