Temp - Associate Scientist, Biologics Analytical Development

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, but few options.

What We Do

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

Designs, develops, and applies the methods for the characterization of gene therapy and other biologic-based development candidates for research, pre-clinical, and clinical use. Analyzes the physico-chemical and biological properties of proteins and gene therapy vectors and establishes the laboratory standards to determine Identity, Strength, Purity, Potency and Quality for research and development candidates.

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Your Contributions (include, But Are Not Limited To)

• Prepares clear and concise technical reports and participates in project team discussions
• Documents 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
• Supports activities associated with the development and execution of methods relevant to protein and gene therapy products for analytical development in a Research and Development environment
• Performs other duties as assigned
• Collaborates 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 decision-making processes within the project team by actively engaging in scientific and technical discussions
• Executes on strategy, vision, and direction set by line management
• Identifies and resolves technical problems through scientific understanding, options assessment, and application of innovative solutions
• Actively contributes to, and assures, the development of, and effective execution of, science-driven, phase appropriate, and risk-based process development strategies to support development projects from lead candidate nomination to clinical development

Requirements

• Strong knowledge of one scientific discipline
• Strong computer skills
• Recognizes fundamental anomalies in data points and identifies issues in experiments / processes
• Good project management skills
• 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 CMC is a plus
• BA/BS in Biochemistry, Biology, or other relevant discipline and 0-2 years of Biotechnology industry experience in biologics including gene therapy-specific techniques OR
• 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
• Some experience with novel methods in AAV characterization (e.g. ddPCR, DLS, AUC, NGS, CE-SDS) preferred
• Good knowledge of cell-based methods associated with bioanalytical analytical method development (e.g. TCID50, Potency assay, viral transduction, and ELISA methods) preferred
• Master's/PhD in relevant discipline and Some similar experience as noted above
• Knowledge of protein and gene therapy biology with a good understanding of testing/characterization methods required
• Good knowledge and demonstrated ability working with a variety of laboratory equipment/tools
• Familiar with laboratory operations, including instrument set up, maintenance, and safety
• Ability to meet deadlines
• Ability to work as part of a team
• Familiar level knowledge of the biologics drug development process is recommended
• Detail oriented
• Good knowledge of scientific principles, methods, and techniques
• Good communications, problem-solving, analytical thinking skills
• Begins to understand how to think outside of the technical process and consider the impact decisions will have on the broader scientific goals

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.