Bioassay Scientist/Sr. Scientist, 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.

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 role will serve as the analytical potency subject matter expert (SME) supporting CMC development for biologics, including antibodies and bioconjugates. The incumbent will be responsible for developing, qualifying/validating, and managing potency assays used to assess and monitor key quality attributes for both drug substance and drug product. This includes contributing to bioassay strategy, method execution, and regulatory-compliant data analysis across all stages of the drug development lifecycle. Work will be performed in compliance with cGMP, safety, and applicable regulatory requirements.

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Your Contributions (include, But Are Not Limited To)

• Lead potency methods development, and qualification/validation activities to support characterization of antibody and antibody conjugate modalities utilizing various bioassays including but not limited to cell-based assays, ELISA, TR-FRET, qPCR, and SPR
• Design, execute, analyze, and interpret bioassay data for process intermediates, drug substance, and drug product across all development stages
• Represent Analytical Development as potency SME on CMC cross-functional teams and maintain accountability for analytical deliverables
• Support analytical method transfer, manufacturing support activities, and technical interactions with external vendors and contract laboratories
• Lab Personnel and ensure laboratory safety practices
• Leverage literature, ICH/Regulatory guidance, and practical experience to perform this work and influence CMC development strategies
• Other duties as assigned
  
  

Requirements

• BS/BA degree in Biology or closely related field and 5 years of pharmaceutical industry experience in an R&D/QC setting, including conducting bioassay analysis and troubleshooting, evaluating analytical data and drawing meaningful conclusions OR
• MS/MA degree in Biology or closely related field and 3 years of similar experience noted above OR
• PhD in Biology or closely related field and some relevant experience; may include post-doc experience
• Strong knowledge of analytical bioassays and antibody-based drug development preferred
• Hands-on experience with antibody and bio-conjugate modalities, with emphasis on analytical development and potency methods
• Proficient in bioassay technologies, including but not limited to: cell-based assays (e.g., proliferation, inhibition, cytotoxicity, reporter/luciferase), immunoassays (e.g., ELISA, TR-FRET), binding assays (e.g., SPR) and molecular biology assays (e.g., qPCR)
• Method development, qualification, validation, and transfer experience in Analytical Development
• Comprehensive understanding of cGMP requirements in drug substance and drug product
• Expert knowledge of cross-functional understanding related to drug development
• Knowledge of FDA, EMA, WHO, and ICH regulatory requirements
• Excellent laboratory and productivity skills
• Excellent interpersonal skills with strong oral and written communication abilities
• Excellent problem solving and critical thinking skills
  
  

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 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 $110,800.00-$151,000.00. 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 20% 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.