Scientist I
On-site · Wilmington, Delaware, United States
Job Summary
Apply advanced bioanalytical and bioassay expertise to support global manufacturing, product quality, and regulatory compliance. Develop, qualify, validate, and manage lifecycle of analytical and bioassay methods used for product quantification and release. Perform statistical quality control (SQC) analysis and data-driven evaluations to identify trends, variability, and improvement opportunities. Establish and maintain enzyme standards and control programs supporting global operations. Collaborate cross-functionally to troubleshoot complex analytical issues and improve process capability. Interpret complex datasets and provide clear, actionable insights to support decision-making. Contribute to continuous improvement of laboratory workflows, systems, and analytical performance. Support technology advancement and adoption of new analytical methods and tools.
Required Qualifications
- Bachelor’s degree with 10+ years experience in bioanalytical methods
- Master’s degree with 5+ years experience in bioanalytical methods
- Ph.D. with 2–3 years experience in bioanalytical methods
- Strong technical expertise in enzymology, HPLC, ELISA, spectroscopy, electrophoresis, and related bioanalytical techniques
- Experience with analytical method development, validation, and lifecycle management
- Proficiency in statistical tools, DOE principles, and root cause analysis
- Ability to interpret complex datasets and provide actionable insights
- Experience collaborating across R&D, QA/QC, Manufacturing, and Regulatory
- Proficiency with LIMS, SAP, SharePoint, and Microsoft Office tools
- Strong communication and influencing skills
- Experience with data analytics or visualization tools
- Project leadership skills without formal supervisory responsibilities
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