This is what you will do:
This Development Scientist II will be a key team member in Alexion’s External Analytical Development and Quality Control group. This position is responsible for maintaining the highest standard of quality and compliance of external quality control testing (GMP) laboratories. This candidate will be responsible for initiation and ownership of laboratory investigations (LIRs) through strong liaison with external contract laboratories and change controls relevant to ADQC biologic programs. The candidate will ensure timely, compliant, and high-quality delivery for LIR closure to enable the generation of final release CoAs. The role will work closely with internal Quality Assurance, Compliance, Analytical Development and Stability teams to ensure product to patients.
You will be responsible for:
Responsible for generating and/or mirroring, reviewing, providing assessments, and driving ownership of LIRs to close out Out-of-Specification (OOS), Out-of-Trend (OOT), and atypical results with structured root cause analysis, impact assessment, and/or corrective/preventive actions (CAPAs).
Create plans, track, and present timelines to meet established targets, goals, and objectives.
You will need to have:
A broad knowledge of Pharmaceutical Quality Assurance, regulatory compliance, and/or quality control inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
We would prefer you to have:
Working knowledge in validated documentation systems: Veeva Vault (EQV), LIMS, ValGenesis, Kneat, etc.
Database management /statistical analysis (e.g., JMP, Tableau, SAS) with proficiency in Microsoft SharePoint and/or BOX.
Date Posted
09-Aug-2026
Closing Date
03-Sep-2026
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.
