Neurocrine Biosciences

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:

This Scientist will guide the design, development, and execution of cell-based and molecular biology methods for the characterization and analysis of gene therapy and other biologic-based assets for research, pre-clinical, and clinical use. They will collaborate with CMC analytical development & therapeutic area leads in analysis to determine the content and potency properties of proteins and gene therapy vectors, working cross-functionally to establish the laboratory standards for determining strength, potency and quality attributes for these late-stage discovery and early development candidates.

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

• Supports activities associated with the development and execution of cell-based methods relevant to protein and gene therapy products for analytical development in a research and development pre-clinical environment
• Establishes assay development parameters such as specificity, linearity, precision, and repeatability of biological assays through optimization of experimental methods
• Leads the timely transfer of the developed assay to CMC/external vendor for QC testing and co-manage external assay development/qualification for release and stability testing of potency at the CROs
• Performs molecular biology techniques (MSD, Western blotting, DNA/RNA extractions, Digital PCR, RT-PCR, quantitative PCR, etc.)
• Identifies, evaluates, and champions new enabling technologies and experimental methods
• Performs rigorous data analysis and provide timely reports/presentations to project teams
• Properly documents experimental designs, findings, and assay protocols, and comply with all laboratory trainings and safety requirements
• Works with a cross-functional 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, GLP toxicology 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
• Contributes to the decision-making processes within each project team by actively engaging in scientific and technical discussions
• Performs other duties as assigned

Requirements:

• Principal Scientist Level: BA/BS in Biochemistry, Biology, or other relevant discipline and 8+ years of Biotechnology industry experience in biologics including gene therapy-specific techniques OR
• Master's/PhD in relevant discipline and 6+ years as noted above
• PhD or equivalent and 4+ years of relevant experience; may include postdoc experience, Gene Therapy positions will require a PhD in Pharmacology, Neuroscience, Endocrinology, Physiology, or closely related discipline
• Sr. Scientist Level: BA/BS in Biochemistry, Biology, or other relevant discipline and 4+ years of Biotechnology industry experience in biologics including gene therapy-specific techniques OR Master's/PhD in relevant discipline and 3+ years as noted above
• PhD or equivalent and some relevant experience; may include postdoc experience, Gene Therapy positions will require a PhD in Pharmacology, Neuroscience, Endocrinology, Physiology, or closely related discipline
• 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
• Relevant experience in molecular biology techniques, mammalian cell culture, development and employment of cell-based assays
• 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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The annual base salary we reasonably expect to pay is $128,200.00-$185,900.00. 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 30% 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.