Principal Scientist, Analytical Development

Neurocrine Biosciences; San Diego (CA); On-site; USD 157,000 - 214,000; Full time

Job summary

Neurocrine Biosciences is seeking a senior Analytical Development leader to guide a sub-team and act as analytical lead across multiple projects, spanning drug substance and drug product development from preclinical through commercial stages.

You will develop and validate testing methods for raw materials, in-process testing, intermediates, API and drug products, with a focus on advancing innovative analytical techniques while maintaining strict cGMP compliance.

Qualifications

• BS/BA in Analytical Chemistry or related discipline with 15+ years in analytical/pharmaceutical development.
• MS/MA in Analytical Chemistry or related discipline with 13+ years of experience.
• PhD in Analytical Chemistry or related discipline with 7+ years of relevant experience; postdoc experience optional.

Responsibilities

• Leads and manages multiple projects; represents Analytical Development on cross-functional teams.
• Manages designs, plans and executes activities to support pre-clinical through commercial development.
• Directs laboratory work and ensures safe laboratory practices.
• Performs analytical development and optimizes methods for preclinical to commercialization.
• Develops and supports off-site analytical transfers and manufacturing interactions.
• Contributes to CMC regulatory documentation and supports related work.
• Guides professional development of direct reports and mentors team members.

Skills

Analytical Chemistry

Cross-functional leadership

Project management

Communication skills

cGMP compliance

Education

BS/BA in Analytical Chemistry

MS/MA in Analytical Chemistry

PhD in Analytical Chemistry

Job description

Who We Are:

Neurocrine Biosciencesis a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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, Facebook and YouTube. (*in collaboration with AbbVie)

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.

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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 on various projects
• Leads the development of intellectual property
• May utilize working knowledge of other related disciplines to provide solutions to a wide range of difficult problems
• Ability to work as part of and lead multiple teams
• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture and longer-term impact on division/company
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management, strong project leadership skills

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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 $156,900.00-$214,000.00. 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 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.