Job Details

Principal Scientist/Sr. Principal Scientist, Analytical Development

About the Role:

This position will serve as the SME for potency method development and analytical development lead for multiple projects, with a focus on antibodies and bio-conjugates. Guide analytical activities related to drug substance and drug product development from preclinical through commercial phase. Develop, establish, and validate/qualify potency methods used to control in process intermediates, drug substance, and drug products. Contribute to the development and implementation of control strategies. 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 potency analytical method development and validation/qualification activities for the characterization of antibodies and/or bio-conjugates utilizing cell-based bioassays, ELISA, and relevant techniques 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.
• Direct laboratory work and/or lab 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 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 findings at varying levels across the company.
• Other duties as assigned.

Requirements:

• BS/BA in Analytical Chemistry/Cell & Molecular Biology 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, bioanalysis, and a thorough understanding of bioprocess as well as formulation development.
• Extensive experience and expertise with antibody and bio-conjugate modalities compounds, focusing on analytical development and potency method development.
• Excellent interpersonal skills with strong oral and written communication abilities.
• Excellent laboratory and productivity skills.
• Proficient in characterization of antibody and bio-conjugate modalities using various modern technologies. They may include but not limited to cell-based potency bioassays, ELISA, LC (RP, SEC, IEX, HILIC), capillary electrophoresis, gel electrophoresis, mass spectrometry, and molecular analysis.
• Method development, validation, qualification, and transfer experience in Analytical Development.
• Comprehensive understanding of cGMP requirements in drug substance and drug product.
• Expert knowledge of cross-functional understanding related to drug development.
• Knowledge of FDA, EMA, WHO, and ICH regulatory requirements.

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer. We are committed to building a diverse, equitable, and inclusive workplace, 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.