Senior Scientist, Gene Therapy Potency – CMC Analytical Development

Senior Scientist, Gene Therapy Potency – CMC Analytical Development page is loaded## Senior Scientist, Gene Therapy Potency – CMC Analytical Development remote type:
On-Site locations:
US CA San Diegotime type:
Full time posted on:
Posted Yesterday job requisition :
R6562##

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 , and follow the company on ,  and . (
* in collaboration with Abb Vie*)##

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.

## 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…