Job Details

Principal 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.

About the Role:

This position will serve as the analytical lead for multiple projects, with a focus on bioconjugates, and peptides/antibodies. Guide analytical activities related to drug substance and drug product development from preclinical through commercial phase. Develop, establish, and validate/qualify testing methods used to control raw materials, in process, intermediates, drug substance, and drug products. Contribute to the development and implementation of control strategies, with special emphasis on advancing innovation in analytical techniques and platforms. Responsible for keeping work in compliance with cGMP, safety, and regulatory requirements. Participates in analysis and evaluation of material and products at all stages of development process. Monitors and evaluates completion of tasks and projects.

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

• Lead analytical development activities for the characterization of antibodies, synthetic peptides, and bioconjugates utilizing LC-MS, MS/MS, Capillary Electrophoresis, iCIEF, SEC, peptide mapping, and modern glycoprotein & carbohydrate characterization techniques.
• Lead analytical methods development and qualification involving process validation and the validation of analytical methods within cGMP compliance in support of preclinical through commercialization.
• Represent Analytical development on cross-functional teams. Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects.
• Conduct laboratory work independently and/or train lab personnel within the company and at external vendors.
• Ensure safe laboratory practices.
• Create and implement novel concepts and techniques to support analytical activities with Chemical and Product Development.
• Support off-site analytical transfers, manufacturing support, and interaction with contractors.
• Authorize analytical related CMC regulatory documents and lead the supporting work.
• Leverage literature, ICH/ Regulatory guidance, and practical experience to perform this work and influence CMC strategies.
• Contribute to development of policies and department strategies.
• Build and enhance internal and external professional relationships.
• Support career development and technical growth of team members.
• Present findings at varying levels across the company.
• Other duties as assigned.

Requirements:

• BS/BA in Analytical Chemistry/Cell & Molecular Biology or related discipline and 15+ years of experience in the analytical/pharmaceutical development field. Experience in method transfer in Analytical Chemistry OR
• MS/MA in Analytical Chemistry or related discipline and 13+ years of experience OR
• PhD in Analytical Chemistry or related discipline and 7+ years of relevant experience; may include postdoc experience.
• Expert knowledge and understanding of analytical chemistry, bioanalysis, and a thorough understanding of bioprocess as well as formulation development.
• Experience and expertise with antibody and/or peptides compounds, including biologics upstream and downstream process development, formulation of injectable and intramuscular biologics, process characterization.
• Excellent interpersonal skills with strong oral and written communication abilities.
• Excellent laboratory and productivity skills.
• Proficient in characterization of antibody and/or peptides compounds using various modern technologies including but not limited to LC (RP, SEC, IE), LC-MS, Capillary Electrophoresis, peptide mapping, Mass Spectrometry, SDS-PAGE, ELISA, gel electrophoresis and modern glycoprotein & carbohydrate characterization cell-based potency assays.
• Method development, validation, qualification, 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.

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.