Description
This role is for an Associate Scientist III in Process Analytical Sciences. The successful candidate will perform assigned experimental tasks to support development and optimization of manufacturing processes or analytical/characterization methods in addition to clinical stability and release testing for Alexion's biotherapeutic candidates.
The Associate Scientist III will work in collaboration with other members of the Analytical Development and Quality Control team as well as other functional areas throughout Process Development. Key responsibilities include:
Performing routine support testing and optimization of phase-appropriate analytical test methods including capillary electrophoresis (cIEF and CE-SDS), ELISA, various HPLC and UPLC methods (SEC, AEX, glycan analysis) and spectrophotometric applications for evaluation of therapeutic proteins.
Author and review SOPs and technical reports assigned.
Assist with investigation and troubleshooting technical issues/problems.
Recognize aberrant test and sample conditions and report to the area manager with an assessment of the circumstances and potential corrective action if appropriate. Write and compile investigation documentation.
Work with various Research and Development teams to support transfer of analytical test methods for development and clinical support.
Maintain knowledge of current scientific principles and theories. Train other lab personnel as assigned in areas of expertise and participate in cross-functional process development teams.
To be successful in this role, you will need:
A Bachelor's or Master's degree in Chemistry, Biochemistry, Molecular and Cell Biology or a related discipline.
3+ years of HPLC/UPLC experience working in a relevant analytical laboratory setting.
Ability to critically evaluate data and provide insight when necessary.
Experience with various analytical test methods such as LC, ELISA, and CE.
Ability to understand and follow written procedures when conducting experiments and applying methods.
Ability to communicate verbally, communicate in a written format and document procedures and data in peer-reviewed laboratory notebooks.
We would prefer you to have:
Work experience in the pharmaceutical or biotech industry.
Experience with assay optimization and qualification for protein therapeutics.
Excellent interpersonal skills and a strong ability to communicate effectively.
Overall understanding of instrumentation associated with protein assays pertaining to biopharmaceuticals.
Knowledge of cGMP and quality guidelines.
Experience with deep learning models (e.g., CNNs) and anomaly detection algorithms (e.g., Isolation Forests); Python skills with TensorFlow/PyTorch and scikit-learn.
Proficiency in MS Office software including Word, Excel, Outlook, and PowerPoint.
Proficiency in Empower, SoftMax and JMP software.
The ability to accurately and independently generate procedures, protocol and reports pertaining to test methods.