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 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, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVie

About the Role:

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• Supports activities associated with the development and execution of biologically based methods relevant to protein and gene therapy products for analytical development in a Research and Development environment

• Performs the activities needed for in vitro analytical testing to screen engineered vector constructs including transfection and transduction read-outs

• Establishes assay development parameters such as specificity, linearity, precision, and repeatability of biological assays through optimization of experimental methods is preferred

• Demonstrates expertise in multi-well plate bioassay optimization, including ELISA-based and protein characterization methods is preferred

• Understands release testing methods used for viral Gene Therapy products; AAV preferred

• Works with a cross-function team to maintain cell lines for biologically based potency assays for Gene Therapy products, specifically AAV

• Contributes through authorship and review of documents for the development and establishment of analytical methods for product characterization to support research and development activities including the in-process and release testing for material manufactured for research and IND-enabling studies

• Represents the group during discussions with Research, Development, and collaborative stakeholders to build scientific knowledge, capabilities, and strategies by providing protein and gene therapy product characterization data to support research and product development decisions

• Contributes to the development of, and effective execution of, science-driven, phase appropriate, and risk-based process development strategies to support development projects in discovery and development phase programs to lead candidate nomination with responsibility to help tech transfer activities for further GMP assay development, testing

• Identifies and resolves technical problems through scientific understanding, options assessment, and application of innovative solutions

• Prepares clear and concise technical reports and participates in project team discussions

• Carries an internal sense of urgency to execute on strategy, vision, and direction set by line management

• Contributes to the decision-making processes within each project team by actively engaging in scientific and technical discussions

• Performs other duties as assigned

• BA/BS in Biochemistry, Biology, or other relevant discipline and 5+ years of Biotechnology industry experience in biologics including gene therapy-specific techniques OR

• Master's/PhD in relevant discipline and 1+ years as noted above

• Familiarity with product and analytical processes such as Quality by Design (QbD) and Quality Risk Management (QRM) tools to support Clinical Manufacturing at the Dev Candidate stage in a phase-appropriate fashion, to support later phase CMC activities is a plus.

• Knowledge of protein and gene therapy biology with a good understanding of testing/characterization methods required

• Good knowledge of cell-based methods associated with bioanalytical analytical method development (e.g., TCID50, Potency assay, viral transduction, and ELISA methods) preferred

• Some experience with methods in AAV characterization (e.g., Mesoscale Diagnostics, AlphaLisa, TCID50, Wes/JESS protein expression, Full versus Empty Characterization assays, DLS) preferred

• Familiar with laboratory operations, including instrument set up, maintenance, and safety

• Familiar level knowledge of the biologics drug development process is recommended

• Familiar knowledge of GLP and GMP requirements as they pertain to protein and gene therapy process development and Quality Control (QC) testing is a plus

• Recognizes fundamental anomalies in data points and identifies issues in experiments / processes

• Understands how to think outside of the technical process and consider the impact decisions will have on the broader scientific goals

• Strong knowledge of one scientific discipline

• Good knowledge of scientific principles, methods, and techniques

• Good knowledge and demonstrated ability working with a variety of laboratory equipment/tools

• Ability to work as part of a team

• Strong computer skills

• Good communications, problem-solving, analytical thinking skills

• Detail oriented

• Ability to meet deadlines

• Good project management 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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