TEMP - Scientist, Bioanalytical Outsourcing

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: Oversees multiple aspects of bioanalysis at contract research organizations (CRO) according to project-relevant regulatory requirements and industry standards. Establish contracts and work orders for bioanalytical projects. Plan and track bioanalytical method development, validation, and sample analysis to support GLP toxicology studies. Individual will possess project management skills and will have strong knowledge in at least one bioanalytical core competency (LC/MS/MS, LC/UV, automation, method development/validation, GLPs, enzyme- or immuno-based assays).

_

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

• Support all aspects of bioanalytical and dose formulation outsourcing (custom reagent preparation, method development, validation, and sample analysis) at bioanalytical CROs according to regulatory requirements and industry standards for both small and large molecules

• Ensure CROs are provided with requisite supplies and information for assay development and sample analysis

• Work with CMC to schedule for reference standard internal standard synthesis, and to plan for certificate of analysis generation and recertification

• Review validation and study protocols, sample analysis plans, bioanalytical and dose formulation data and reports to ensure regulatory alignment

• Plan and track bioanalytical and dose formulation method development, validation and sample analysis activities to meet data requirements in accordance with study protocols and project deliverables

• Attend regular meetings with CROs to obtain study updates. Capture important expectations and agreed to tasks in post-meeting minutes, share minutes with CROs and relevant NBI personnel

• Work with R&D Strategy and Operations to establish contracts and work orders for bioanalytical projects

• Provide routine status updates to NBI stakeholders: Toxicology, Pharmacokinetics, Finance and R&D Strategy and Operations

• Other tasks as assigned

Requirements:

• BS/BA degree in science related field or similar and 2+ years of pharmaceutical/biotech experience. Experience in managing clinical Contract Research Organizations, preparation of INDs, CTDs, NDAs, and MAAs and working in a cross functional team and matrix environment. Experience developing small/large molecule compounds for CNS indications and silico modeling and simulation tools is beneficial OR

• MS/MA degree in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline and 1+ years of similar experience noted above

• Experience supporting the development, validation, and troubleshooting of bioanalytical methods and sample analysis in one or more of the following disciplines: small molecule, peptides, antibodies, and gene therapy

• Knowledgeable on current regulatory guidance/regulations (FDA/ICH M10)

• Demonstrates solid level of understanding project/group goals and methods

• Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes

• Moderate knowledge of scientific principles, methods and techniques in small or large molecule bioanalysis

• Detail oriented yet can see broader picture of scientific impact on team

• Strong project management skills

• Excellent computer skills

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

• Strong project management skills

• Excellent problem-solving and analytical thinking skills

• Strong written, presentation, and verbal communication skills

• Proactive, innovative, with good problem-solving skills

• Ability to work as part of a team

#LI-OB1

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 dont line up to exactly what we have outlined in the job description.