Associate Scientist II, Process Analytical Sciences
On-site · New Haven, Connecticut, United States
Job Summary
Assesses and supports development and optimization of manufacturing processes and analytical/characterization methods for biotherapeutics. Performs routine support testing and optimization of analytical methods including cIEF and CE-SDS, ELISA, various HPLC/UPLC methods (SEC, AEX, glycan analysis) and spectrophotometric applications to evaluate therapeutic proteins. Authors and reviews SOPs and technical reports; assists with investigations and troubleshooting; participates in method qualification and transfer, and supports cross-functional process development with other R&D teams. Requires lab-based work with capability to lift/carry 15–30 pounds and work with biological, infectious, and hazardous materials; training and mentoring of other lab personnel; strong data evaluation, problem solving, and documentation skills. Preferred: industry experience in pharmaceutical/biotech, assay optimization/ qualification, and knowledge of cGMP and related software tools; familiarity with Python, TensorFlow/PyTorch, scikit-learn, Empower/Softmax/JMP.
Required Qualifications
- Bachelor’s or master’s degree in chemistry, Biochemistry, Molecular and Cell Biology or related discipline
- 2+ years of HPLC/UPLC experience in an analytical laboratory
- Experience with analytical test methods such as LC, ELISA, and CE
- Ability to understand and follow written procedures and document procedures and data in laboratory notebooks
- Ability to communicate effectively in verbal and written formats
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