Sr. Scientist, Critical Reagents

Sr. Scientist, Critical Reagents page is loaded## Sr. Scientist, Critical Reagents remote type:
On-Site locations:
US CA San Diegotime type:
Full time posted on:
Posted Yesterday job requisition :
R6567##

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:

We are seeking a highly motivated Senior Scientist to lead the outsourcing and lifecycle management of critical reagents supporting programs from Research through Clinical development. This role will provide technical leadership and hands-on oversight for the generation, characterization, qualification, and supply of critical reagents used in nonclinical and clinical studies.
The ideal candidate has direct experience developing critical reagents (labeled reference materials, polyclonal antibodies, anti-idiotype antibodies, peptide pools, etc.) and working with external partners to ensure quality, compliance, and continuity of supply. This individual will work cross-functionally to ensure reagent readiness aligned with developmental program timelines. ## Your Contributions (include, but are not limited to):
* Lead external development and qualification of critical reagents to support bioanalytical assays from non-GLP through clinical
* Provide scientific oversight for reagent generation, characterization, comparability, and stability
* Ensure appropriate documentation and traceability to support regulatory expectations
* Identify and evaluate external vendors for reagent generation and long-term supply
* Manage day-to-day CRO/CDMO interactions, including timelines, deliverables, and issue resolution
* Monitor vendor performance and proactively mitigate risks to supply or quality
* Develop lifecycle plans for critical reagents from early research through clinical phases
* Support change management activities, including reagent bridging and comparability assessments
* Ensure reagents meet appropriate GxP requirements based on development stage
* Work with Preclinical Operations to establish contracts and work orders for critical reagent generation
* Establish and manage active inventory to ensure consistent material traceability and availability for use across cross-functional teams and external partners
* Lead reoccurring cross functional discussions around strategy and ongoing campaign updates

* Cross-Functional Collaboration:

Partner with Bioanalytical, CMC, Nonclinical, Clinical, Regulatory, Research, Legal, and Quality teams to align reagent strategies with program needs## Requirements:
* MS in Biology, Biochemistry, Immunology, Pharmaceutical Sciences, or related discipline with 3+ years of industry experience; or BS with 5+ years
* Direct experience generating and/or developing critical reagents (e.g., monoclonal antibodies, PK/ADA/NAb assay reagents, biomarkers, reference standards)
* Experience working with external CROs/CDMOs
* Strong understanding of bioanalytical assay development and reagent qualification
* Strong understanding of GLP/GCLP/GMP requirements as applicable to reagent use
* Working knowledge of regulatory expectations for critical reagents supporting INDs and clinical programs#LI-LS1

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. The annual base salary we reasonably expect to pay is $-$.

Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of…