Principal Scientist, Analytical Development

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

Benefits offered by this job

Retirement plan

Paid vacation

Medical, dental & vision benefits

Professional development opportunities

Job summary

Neurocrine Biosciences in San Diego seeks a senior analytical development leader to guide activities from preclinical through commercial drug substance and product. You will develop, validate and transfer analytical methods, and establish control strategies to ensure product quality.

Join a collaborative, high-impact team focused on advancing innovation in analytical chemistry while maintaining strict cGMP compliance and regulatory readiness across development programs.

Qualifications

• BS/BA in Analytical Chemistry or related field with 15+ years' experience.
• Experience in method transfer in Analytical Chemistry or MS/MA with 13+ years.
• PhD in Analytical Chemistry or related field with 7+ years.

Responsibilities

• Leads and manages multiple analytical development projects.
• Represents Analytical Development on cross-functional teams.
• Maintains accountability for analytical deliverables and CMC plans for development projects.
• Directs laboratory work and ensures safe laboratory practices.
• Develops, validates and transfers analytical methods.

Skills

Analytical Chemistry

cGMP Compliance

Method Development

Method Transfer

Project Leadership

Cross-functional Collaboration

Regulatory Documentation

Education

BS/BA in Analytical Chemistry

MS in Analytical Chemistry

PhD in Analytical Chemistry

Job description

Who We Are:

Neurocrine Biosciences is 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.

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 optimises 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.
• Neurocrine Biosciences is an EEO/Disability/Vets employer.

Annual Salary and Benefits:

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.

We are a top place to work. Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma™ 2025. We were also named a Great Place to Work® Certified company.

OUR VALUES:

PASSION: We are driven and love what we do. We are committed to our goals and to making a difference.

INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up.

COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed.

INNOVATION: We seek and create optimal solutions.

TENACITY: We do not quit. We adapt. We accomplish what others cannot.

Come join our team during this exciting time of growth and opportunities!