Scientist II
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 communicate clear, actionable insights to stakeholders. Support continuous improvement of laboratory workflows, systems, and analytical performance. Contribute to adoption of new analytical technologies and digital tools across the function. Hands-on onsite role with a focus on global product quality and manufacturing excellence.
Required Qualifications
- Bachelor’s degree with 10+ years, Master’s degree with 5+ years, or Ph.D. with 2–3 years of relevant experience
- 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 (Design of Experiments) principles, and root cause analysis
- Ability to interpret complex datasets and recommend scientifically sound solutions
- Proven collaboration across R&D, QA/QC, Manufacturing, and Regulatory functions
- Strong communication skills with the ability to influence and present technical findings
- Proficiency with LIMS, SAP, SharePoint, and Microsoft Office tools
Desired Qualifications
- Experience with enzymology, HPLC, ELISA, spectroscopy, electrophoresis; analytical method development, validation, and lifecycle management; proficiency in statistical tools, DOE, and root cause analysis; collaboration across R&D, QA/QC, Manufacturing, and Regulatory; proficiency with LIMS, SAP, SharePoint, and Microsoft Office; experience with advanced data analytics or visualization tools
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