Principal Scientist, Analytical Development

Neurocrine Biosciences • San Diego, CA

3d

About The Position

This position serves as the analytical lead for multiple projects, with a focus on gene therapy and biologics. The role guides analytical activities supporting drug substance and drug product development from preclinical through commercial phases. Responsibilities include developing, establishing, and validating or qualifying analytical methods to control raw materials, in-process materials, intermediates, and drug substance and product. The position contributes to the development and implementation of control strategies, with an emphasis on advancing innovative analytical techniques. The role also ensures compliance with cGMP, safety, and regulatory requirements, and supports the analysis and evaluation of materials and products at all stages of the development process. Additionally, the position monitors progress and evaluates the completion of assigned tasks and projects.

Requirements

• BS/BA and 12+ years of experience, or OR MS/MA and 10+ years of experience, or OR PhD or equivalent and 4+ years of relevant experience
• Expert knowledge and understanding of analytical chemistry, bioanalysis, and a thorough understanding of bioprocess as well as formulation development
• Method development, validation, and transfer experience in Analytical Development
• Proficient in characterization of gene therapy and/or biologic compounds using various modern technologies. They may include but not limited to high-resolution MS, SEC, CE (icIEF/CE-SDS), SV-AUC, DSC, CD, and plate-based assays
• Experience and expertise with gene therapy and/or biologic compounds, including cell line banks, plasmids, viral vectors, and residual host cell proteins/DNA
• Excellent interpersonal skills with strong oral and written communication abilities
• Excellent laboratory and productivity skills
• Knowledge of FDA, EMA, WHO, and ICH regulatory requirements
• Comprehensive understanding of cGMP requirements in drug substance and drug product
• Expert knowledge of cross-functional understanding related to drug development

Responsibilities

• Lead analytical development and characterization activities for multiple projects with focus on gene therapy and biologic compounds
• Represent Analytical development on cross-functional teams.
• Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects
• Design, plan, and execute activities towards the goals of one or more analytical development projects to support pre-clinical through commercial activities
• Execute characterization of gene therapy and biologic modalities using high-resolution mass spectrometry, chromatographic separations, and other biophysical methodologies.
• Perform laboratory work and/or direct lab personnel within the company and at external vendors
• Ensure safe laboratory practices
• Perform analytical development and methods optimization in support of preclinical through commercialization
• Create and implement novel concepts and techniques to support analytical activities with Chemical and Product Development
• Support off-site analytical transfers, manufacturing support, and interaction with contractors
• 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 finding at varying levels across the company
• Other duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans
• annual bonus with a target of 30% of the earned base salary
• eligibility to participate in our equity based long term incentive program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees