Principal Scientist/ Sr. Principal Scientist – Analytical Development
| Company | Neurocrine Biosciences |
|---|---|
| Location | San Diego, CA, USA |
| Salary | $153800 – $222850 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Expert or higher |
Requirements
- BS/BA and 15+ years of experience, or OR
- MS/MA and 13+ years of experience, or OR
- PhD or equivalent and 7+ years of relevant experience
- Expert knowledge and understanding of analytical chemistry, bioanalysis, and a thorough understanding of bioprocess as well as formulation development
- 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
- Proficient in characterization of gene therapy and/or biologic compounds using various modern technologies. They may include but not limited to ddPCR, NGS, ELISA, high resolution MS, cell-based potency assays, HPLC, and CE
- 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
- Knowledge of FDA, EMA, WHO, and ICH regulatory requirements
Responsibilities
- Lead analytical development work for multiple projects, primarily gene therapy compounds, including cell line banks, plasmids, viral vectors, and residual host cell proteins/DNA. 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
- Direct laboratory work and/or 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
Preferred Qualifications
-
No preferred qualifications provided.