Sr. Principal Scientist, Analytical Development; Molecule San Diego

Position: Sr. Principal Scientist, Analytical Development (Small Molecule San Diego Based)
Sr. Principal Scientist, Analytical Development page is loaded## Sr. Principal Scientist, Analytical Development remote type:
On-Site locations:
US CA San Diegotime type:
Full time posted on:
Posted Yesterday job requisition :
R5800##

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:

** Responsible for leading a sub-team in analytical development and/or serve as an analytical lead for multiple projects to guide the analytical activities for supporting drug substance and drug product development from preclinical through commercial phase. Develops, establishes and validates testing methods used to control raw materials, in process testing, intermediates, API and drug products. Responsible for development and implementation control strategies, with special emphasis on advancing innovation in analytical techniques.

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):
* Leads and manages multiple projects. Represents Analytical Development on cross-functional teams. Maintains accountability for analytical deliverables and progress on CMC plans for all development projects
* Manages designs, plans and executes activities towards the goals of one or more analytical development projects to support pre-clinical through commercial activities
* Directs laboratory work and/or lab personnel and ensures safe laboratory practices
* Performs analytical development and optimizes methods in support of preclinical through commercialization
* Creates and implements novel ideas and techniques to support analytical activities with Chemical and Product Development
* Develop and support off-site analytical transfers, manufacturing support and interaction with contractors
* Supplies input into CMC regulatory documentation and supporting work
* Facilitates effective supervision of laboratory personnel and guidance for their professional development
* Leverages literature, ICH/ Regulatory guidance, and practical experience to perform their work and influence CMC strategies
* Contributes to development of policies and department strategies
* Builds and enhances internal and external professional relationships
* Supports career development and technical growth of direct reports
* Presents finding at varying levels across the company
* Other duties as assigned## Requirements:
* BS/BA in Analytical Chemistry 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 and a thorough understanding of process chemistry as well as formulation development
* Excellent interpersonal skills with strong oral and written communication abilities
* Excellent laboratory and productivity skills
* Method development, validation, and transfer experience in Analytical Development
* Comprehensive understanding of cGMP requirements in API and drug product
* Expert knowledge of cross-functional understanding related to drug development
* Applies understanding of the team's place in the larger organization, and discusses changes, progress, and issues as they relate to other areas
* Maintains substantial knowledge of principles and theories and acts as a technical lead…