Development Scientist II, Analytical Development and Clinical QC (ADQC)

This Development Scientist II will be a key team member in Alexion’s External Analytical Development and Quality Control group, responsible for maintaining the highest standard of quality and compliance of external quality control testing (GMP) laboratories.

Responsibilities

• Generate, mirror, review, assess, and drive ownership of Laboratory Investigational Reports (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).
• Design investigational testing plans ensuring compliant closure of all testing-related investigations within the quality system.
• Lead and/or facilitate cross-functional meetings with Quality Assurance to ensure structured investigation alignment.
• Create plans, track, and present timelines to meet established targets, goals, and objectives.
• Perform review of analytical data to ensure expected assay performance.
• Identify opportunities for improvement in systems and make recommendations for effective changes to ensure compliance with cGMP.
• Demonstrate strong presentation skills.

Requirements

• Strong mental acuity with high attention to detail and ability to maintain accuracy in documentation and processes.
• Excellent analytical and problem-solving skills with the ability to conduct risk assessments and root cause analysis.
• Broad knowledge of Pharmaceutical Quality Assurance, regulatory compliance, and/or quality control inclusive of cGMP, FDA regulations, familiarity with ICH guidelines, and EU regulations.
• Strong proficiency in quality management systems and effective communication skills for interacting with cross-functional teams.
• Strong proficiency with MS Word, Excel, and PowerPoint.
• Ability to bend, reach, and stand, with lifting up to 15 pounds and carrying over short distances.
• Ability to travel up to 10%, if needed.

Qualifications

• Advanced degree (M.S. or Ph.D.) in Biochemistry, Chemistry, or a related discipline.
• 2–5 years (Ph.D.) or 10+ years (M.S.) of hands-on biological analytical development experience in the pharmaceutical industry.

Skills

• Working knowledge of validated documentation systems: Veeva Vault (EQV), LIMS, ValGenesis, Kneat, etc.
• Knowledge of pharmaceutical/biotechnology manufacturing processes.
• 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