TEMP - Associate Scientist / Scientist, Biologics Characterization, Biologics Lead Optimization

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: We are in search of a collaborative, passionate scientist with sound scientific knowledge and excellent technical skills in molecular biology and analytical sciences for AAV gene therapy and other biologics. In the analytical development group in the biologics lead optimization team, you will be responsible for performing routine analytical tests and developing/optimizing analytical methods to support the development and manufacturing of AAV based gene therapy products and other biologic therapeutics. In this role, you will collaborate across multiple groups including process development, CMC, research, as well as CROs to ensure all applicable analytical test methods are appropriate for the stages of preclinical & clinical development.

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

• Develop and optimize robust PCR based, ELISA based and protein/DNA characterization methods for process monitoring and AAVs/other biologics drug substance characterization and release

• Apply molecular biology techniques to quantitatively/semi-quantitatively measure AAV genome size, AAV product nucleic acid impurities and process residuals

• Make detailed observations, analyze data, interpret results, prepare reports, and exercise appropriate technical judgment in the design, execution, and interpretation of experiments

• Execute experiments in a timely fashion to support scientific activities and project goals/deliverables

• Perform rigorous data analysis and present scientific findings at internal and external meetings

• Contribute to the timely transfer of the developed/optimized assay to CMC/external vendor/s for QC testing and provide oversight for external assay development/qualification for release and stability testing of AAVs at the CROs as needed

• Contribute through authorship and review of documents to 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 other IND-enabling studies

• Evaluate new analytical methods/instruments and make recommendations regarding their use

Requirements:

• Bachelor's degree in relevant scientific discipline with at least 1+ years relevant industry experience or master's degree in relevant scientific discipline with some relevant industry experience or PhD in relevant scientific discipline with/without post-doctoral experience

• Position level will be determined depending on years of experience and industry experience

• Experience in qPCR, digital PCR, design of primer/probe sets, ELISA, HPLC (RP, SEC) and CE based methods

• Experience in analytical method development, method transfer, method qualification are desired but not required

• Ability to independently plan and perform experiments for assay development, product release/stability/characterization, support for project activities with minimal supervision

• Ability to interpret data, draw conclusions, and recommend next steps

• Ability to identify and solve technical challenges

• Ability to determine methods and procedures and communicate them to others

• Ability to recommend alternatives as well as research new methods and techniques

• Ability to effectively communicate information and results in the appropriate format (i.e. lab notebooks, presentations, etc.)

• Prior industry experience preferred

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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.