Principal Scientist, Analytical Development

Principal Scientist, Analytical Development page is loaded## Principal Scientist, Analytical Development remote type:
On-Site locations:
US CA San Diegotime type:
Full time posted on:
Posted Todayjob requisition :
R6396##

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 , and follow the company on ,  and . (
* in collaboration with Abb Vie*)##

About the Role:

This position will serve as the analytical lead for multiple projects, with a focus on bioconjugates, and peptides. 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 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 finding at varying levels across the company
* Other duties as assigned## Requirements:
* BS/BA in Analytical Chemistry/Biochemistry/Cell & Molecular Biology or related discipline and 15+ years of experience in the analytical/pharmaceutical development field 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 peptides compounds and conjugates, including analytical controls in peptide synthesis, conjugation process, formulation of injectable biologics, and process characterization
* Excellent interpersonal skills with strong oral and written communication abilities
* Excellent laboratory and productivity skills
* Proficient in characterization of peptides and/or conjugates compounds using various modern technologies. They may include but not limited to LC (RP, SEC, IE), LC-MS,…