Sr. Scientist / Principal Scientist, Biologics Characterization

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:

Analytical Development group in Biologics Lead Optimization is seeking a highly motivated Sr. Scientist/Principal Scientist with focus on analytical techniques for characterization of AAV gene therapies and other biologics. The candidate should be proficient in both assay development and characterization of rAAV gene therapies. The candidate will work collaboratively with our therapeutic areas, production and CMC teams to advance Neurocrine’s preclinical biologics portfolio. The ideal candidate will have biotechnology experience in biologics process and analytical development. Individual will be responsible for assisting with the development and execution of analytical methods to support research and preclinical studies and interface with CMC and will participate in analysis and evaluation of material and products at all stages of development process, as well as monitoring completion of tasks and projects.

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

• Develop and optimize robust physicochemical and biophysical characterization methods for assessing product quality of AAV gene therapies and other biologics including Particle size analysis, AAV capsid distribution (various), Aggregation & Purity, Charge heterogeneity, Intact mass analysis, post translational modifications and Thermodynamic analysis

• Represent early-phase analytical development on cross-functional teams. Maintain accountability for analytical deliverables and progress on lead optimization and manufacturing plans for all development projects

• Analyze experimental data, generate plots and summarize results and conclusions

• Maintain comprehensive Electronic Lab Notebook documenting experiments

• Maintain a high level of productivity in the team with clear daily, detailed, and accurate documentation of experiments

• Collaborate with team members to meet project goals, and advance novel biologic candidates into pipeline

• Author analytical method protocols, technical reports, transfer documents and supporting documents for regulatory filings

• Support off-site analytical method transfers, manufacturing support, and interaction with CMC and external vendors

• Build and enhance internal and external professional relationships

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

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

• Proficient in characterization of different biologic modalities using various modern technologies. They may include but not limited to Analytical ultracentrifugation (AUC), Mass photometry, Size exclusion chromatography (SEC), Reverse phase chromatography, Ion exchange chromatography(IEX), Capillary gel electrophoresis (CGE), Mass spectrometry, Light scattering techniques (DLS, MALS) and Molecular analysis.
• Ability to independently plan and perform experiments for assay development, product release/stability/characterization, support for project activities with minimal supervision. Method development, qualification, and method transfer experience in Analytical Development.
• Ability to interpret data, draw conclusions, and recommend next steps.
• Ability to identify and solve technical challenges.
• 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.
• Excellent interpersonal skills with strong oral and written communication abilities
• Excellent laboratory and productivity 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.