Principal Scientist/Sr. Principal Scientist, Analytical Development

Neurocrine Biosciences; San Diego (CA); On-site; USD 153,000 - 223,000; Full time

Job summary

An established industry player is seeking a Subject Matter Expert in potency method development to lead analytical activities for innovative therapies. This role involves guiding the development of critical methods and ensuring compliance with regulatory standards. You will collaborate with cross-functional teams and external vendors, contributing to the advancement of life-changing treatments for neurological disorders. Join a passionate team dedicated to improving patient outcomes and making a significant impact in the biopharmaceutical field. If you are driven by science and innovation, this is the opportunity for you.

Benefits

Retirement Plan

Paid Time Off

Parental Leave

Comprehensive Health Coverage

Medical Leave

Qualifications

• 15+ years of experience in analytical/pharmaceutical development.
• Expertise in analytical chemistry and potency method development.
• Understanding of cGMP requirements for drug substances.

Responsibilities

• Lead potency analytical method development for antibodies and bio-conjugates.
• Ensure compliance with cGMP and regulatory requirements.
• Support off-site analytical method transfers and external vendor interactions.

Skills

Analytical Chemistry

Bioanalysis

Bioprocess Development

Formulation Development

Interpersonal Skills

Communication Skills

Education

BS/BA in Analytical Chemistry or related discipline

MS/MA in Analytical Chemistry or related discipline

PhD in Analytical Chemistry or related discipline

Tools

ELISA

LC

Mass Spectrometry

Capillary Electrophoresis

Gel Electrophoresis

Job description

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. Our 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 in mid- to late-phase clinical development across core therapeutic areas. For three decades, we have applied our insights into neuroscience and the brain-body connection to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases because you deserve brave science. For more information, visit neurocrine.com and follow us on LinkedIn, X, and Facebook. (*in collaboration with AbbVie)

About the Role:

This position will serve as the SME for potency method development and analytical development lead for multiple projects, focusing on antibodies and bio-conjugates. You will guide analytical activities related to drug substance and drug product development from preclinical through commercial phases. Develop, establish, and validate/qualify potency methods to control in-process intermediates, drug substance, and drug products. Contribute to the development and implementation of control strategies. Ensure compliance with cGMP, safety, and regulatory requirements. Participate in analysis and evaluation of materials and products at all stages of development. Monitor and evaluate task and project completion.

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

• Lead potency analytical method development and validation/qualification activities for antibodies and/or bio-conjugates using cell-based bioassays, ELISA, and relevant techniques within cGMP compliance supporting preclinical through commercialization phases.
• Represent Analytical Development on cross-functional teams. Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects.
• Direct laboratory work and/or personnel within the company and at external vendors.
• Ensure laboratory safety practices.
• Support off-site analytical method transfers, manufacturing support, and interaction with external vendors.
• Provide input into CMC regulatory documentation and supporting work.
• Leverage literature, ICH/Regulatory guidance, and practical experience to perform work and influence CMC strategies.
• Contribute to the development of policies and departmental strategies.
• Build and enhance internal and external professional relationships.
• Support career development and technical growth of team members.
• Present findings at various levels across the company.
• Perform other duties as assigned.

Requirements:

• BS/BA in Analytical Chemistry/Cell & Molecular Biology or related discipline with 15+ years of experience in analytical/pharmaceutical development, including method transfer experience.
• 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, including postdoc experience.
• Expertise in analytical chemistry, bioanalysis, bioprocess, and formulation development.
• Extensive experience with antibody and bio-conjugate modalities, focusing on analytical and potency method development.
• Strong interpersonal, communication, and laboratory skills.
• Proficiency in modern characterization technologies such as cell-based potency bioassays, ELISA, LC, capillary electrophoresis, gel electrophoresis, mass spectrometry, and molecular analysis.
• Experience in method development, validation, qualification, and transfer within Analytical Development.
• Understanding of cGMP requirements for drug substances and drug products.
• Knowledge of FDA, EMA, WHO, and ICH regulatory standards.

#LI-DM1

Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to a workplace of belonging, respect, and empowerment, encouraging applications from candidates of diverse backgrounds even if their experience does not match all outlined qualifications.

The annual base salary range is $153,800 - $222,850, with potential bonuses and long-term incentives. Benefits include a retirement plan, paid time off, parental and medical leave, and comprehensive health coverage.