Associate Scientist II, Process Analytical Sciences

This is what you will do:

The Associate Scientist II will be responsible for performing 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. This individual will work in collaboration with other members of the Analytical Development and Quality Control team as well as other functional areas throughout Process Development. The Associate Scientist will provide analytical method support pertaining to LC, CE-SDS, cIEF, ELISA and potency assays. Participation in method qualification and transfer, optimization and troubleshooting of methods to internal and external laboratories may be required.

You will be responsible for:

• 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 as 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.

You will need to have:

• Bachelor’s or master’s degree in chemistry, Biochemistry, Molecular and Cell Biology or related discipline.
• 2+ years of HPLC/UPLC experience working in a relevant analytical laboratory setting.
• Ability to critically evaluate data and provide incite 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.
• The duties of this role are conducted in a lab environment.  As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

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.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.